226. 間質性膀胱炎(ハンナ型) Interstitial cystitis with Hunners ulcer Clinical trials / Disease details


臨床試験数 : 143 薬物数 : 171 - (DrugBank : 56) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 145

  
80 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05062902
(ClinicalTrials.gov)
January 1, 202316/9/2021A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain ManagementAn Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain ManagementInterstitial Cystitis;Chronic Pain;Pelvic Floor; Relaxation;Pelvic Floor DisordersDevice: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device;Drug: Botulinum NeurotoxinHillMed Inc.Baylor College of Medicine;University of HoustonNot yet recruiting18 Years60 YearsFemale46Early Phase 1United States
2NCT04734106
(ClinicalTrials.gov)
May 202227/1/2021Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial CystitisA Double-Blind, Placebo-Controlled Study to Establish the Safety and Efficacy of Super-Concentrated, Freeze-Dried Aloe Vera in the Management of the Symptoms of Interstitial CystitisInterstitial Cystitis;Chronic Interstitial Cystitis;Bladder Pain SyndromeDrug: Desert Harvest Aloe Vera Capsules;Other: Placebo CapsulesWake Forest University Health SciencesDesert HarvestNot yet recruiting18 YearsN/AAll100Early Phase 1United States
3JPRN-jRCTs051210106
13/10/202113/10/2021ESTOC studyThe Effect of Suplatast Tosilate for interstitial Cystitis: A randomized controlled open-label trial - ESTOC study Interstitial cystitis
bladder, inflammation, pain;D018856
Participants will be randomly assigned to splatast group or control group.
In splatast group, splatast tosilate capsule 100 mg (1 capsule at a time) will be orally administered 3 times a day between meals for 3 months. In control group, flavoxate hydrochloride tablets 200 mg (1 tablet at a time) will be orally administered 3 times a day between meals for 3 months.
Torimoto KazumasaFujimoto KiyohideRecruiting>= 20age oldNot applicableBoth100Phase 2Japan
4NCT04313972
(ClinicalTrials.gov)
September 7, 202116/3/2020IC PaIN Trial: Interstitial Cystitis Pain Improvement With NaltrexoneIC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone, the Effect of Low Dose Naltrexone on Symptoms and Pain of Patients With Interstitial Cystitis/Painful Bladder Syndrome a Randomized Placebo-controlled Prospective TrialInterstitial Cystitis;Painful Bladder Syndrome;Bladder Pain Syndrome;Low Dose Naltrexone;Low-dose Naltrexone;NaltrexoneDrug: low-dose naltrexone;Drug: Placebo oral tabletNorthShore University HealthSystemNULLRecruiting18 Years110 YearsFemale44Phase 4United States
5NCT05275647
(ClinicalTrials.gov)
May 18, 202113/1/2022Efficacy and Safety of Low Energy Shock Wave Plus BotulinumToxin A in Treating Patients With Interstitial CystitisTherapeutic Efficacy and Safety of Low Energy Shock Wave (LESW) Plus Botulinum Toxin A Instillation in Treatment of Patients With Interstitial Cystitis Refractory to Conventional Therapy - A Clinical and Immunohistochemistry StudyInterstitial CystitisDrug: BOTOX 100U in normal saline;Drug: Normal salineBuddhist Tzu Chi General HospitalMinistry of Science and Technology, Taiwan;Hualien Tzu Chi General HospitalRecruiting20 YearsN/AAll75Phase 2Taiwan
6NCT04789135
(ClinicalTrials.gov)
March 20, 20201/3/2021Evaluation of Response to Use of Intravesical Ozone Gas in Interstitial Cystitis /Bladder Pain SyndromeEvaluation of Response to Use of Intravesical Ozone Gas in Interstitial Cystitis/Bladder Pain SyndromeInterstitial Cystitis, Chronic;Bladder Pain SyndromeDrug: OzoneAnhembi Morumbi UniversityNULLActive, not recruitingN/AN/AFemale50Phase 2Brazil
7NCT03844412
(ClinicalTrials.gov)
November 4, 201915/2/2019Vestibulodynia: Understanding Pathophysiology and Determining Appropriate TreatmentsVestibulodynia: Understanding Pathophysiology and Determining Appropriate TreatmentsVestibulodynia;Temporomandibular Disorder;Fibromyalgia Syndrome;Irritable Bowel Syndrome;Migraines;Tension Headache;Endometriosis;Interstitial Cystitis;Back Pain;Chronic Fatigue SyndromeDrug: 5% lidocaine/5 mg/ml 0.02% estradiol compound cream;Drug: Nortriptyline;Drug: Placebo cream;Drug: Placebo pillDuke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Recruiting18 Years50 YearsFemale400Phase 2United States
8EUCTR2016-004138-12-BE
(EUCTR)
27/11/201719/07/2017Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLNot Recruiting Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Poland;Spain;Belgium;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
9NCT03143920
(ClinicalTrials.gov)
November 1, 20172/5/2017Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary BladderHyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder: A Feasibility TrialChronic Interstitial Cystitis;Painful Bladder Syndrome;Recurrent Urinary Tract InfectionCombination Product: Hyperbaric Oxygen Therapy-University of California, San DiegoNULLRecruiting35 Years70 YearsFemale40Early Phase 1United States
10EUCTR2016-004138-12-GB
(EUCTR)
30/10/201717/07/2017Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
11EUCTR2016-004138-12-NL
(EUCTR)
23/10/201724/07/2017Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not Applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLNot Recruiting Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Latvia;Germany;Netherlands;United Kingdom
12JPRN-UMIN000029113
2017/10/1020/09/2017Clinical study on the effect of fermented buckwheat sprouts in patients with interstitial cystitis Patients with interstitial cystitisIngestion of test food including fermented buckwheat sprouts (12 weeks, 4 tablets / once a day)Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of ShizuokaKageyama Hospital (Shizuoka city)Nakamura Hospital (Beppu city)Pending20years-oldNot applicableMale and Female20Not selectedJapan
13EUCTR2016-004138-12-PL
(EUCTR)
27/09/201719/07/2017Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
163Phase 2Hungary;Czech Republic;Belgium;Spain;Poland;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
14EUCTR2016-004138-12-DE
(EUCTR)
26/09/201710/07/2017Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLNot Recruiting Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
15NCT03463499
(ClinicalTrials.gov)
September 22, 201725/2/2018The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome PatientsThe Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome PatientsInterstitial CystitisDrug: Hyaluronic Acid and Chondroitin SulfateSamsung Medical CenterNULLActive, not recruiting20 YearsN/AAll62N/AKorea, Republic of
16EUCTR2016-004138-12-ES
(EUCTR)
18/09/201718/09/2017Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000017419;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
163Phase 2Hungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
17EUCTR2016-004138-12-HU
(EUCTR)
14/09/201712/07/2017A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000017419;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
163Phase 2Czech Republic;Hungary;Spain;Poland;Belgium;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
18EUCTR2016-004138-12-CZ
(EUCTR)
30/08/201713/07/2017Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
163Phase 2Hungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
19EUCTR2016-004138-12-LV
(EUCTR)
04/08/201725/07/2017Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000017419 ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP6294
INN or Proposed INN: Not applicable
Other descriptive name: ASP6294
Astellas Pharma Europe B.V.NULLNot Recruiting Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Netherlands;Germany;Latvia;United Kingdom
20EUCTR2016-000906-12-NL
(EUCTR)
15/06/201719/07/2017A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain SyndromeThe LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by a 40-Week Extension Period - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 19.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857
MedDRA version: 19.1;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857 ;Therapeutic area: Not possible to specify
Product Code: AQX-1125
INN or Proposed INN: AQX-1125
Other descriptive name: AQX-1125
Aquinox Pharmaceuticals (Canada) Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Netherlands;Germany;Latvia
21EUCTR2016-000906-12-BE
(EUCTR)
24/04/201716/01/2017A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain SyndromeThe LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000017419
MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000017419;Therapeutic area: Not possible to specify
Product Code: AQX-1125
INN or Proposed INN: AQX-1125
Other descriptive name: AQX-1125
Aquinox Pharmaceuticals (Canada) Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Germany;Latvia;Netherlands
22NCT03104361
(ClinicalTrials.gov)
April 20173/4/2017Platelet-Rich Plasma (PRP) Injection in Treatment of Interstitial CystitisIntravesical Injections of Platelet-Rich Plasma (PRP) in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Clinical TrialInterstitial CystitisBiological: Platelet-Rich PlasmaBuddhist Tzu Chi General HospitalNULLNot yet recruiting20 YearsN/AAll30Phase 1Taiwan
23EUCTR2016-000906-12-ES
(EUCTR)
02/03/201716/01/2017A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain SyndromeThe LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by a 40-Week Extension Period - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 19.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857
MedDRA version: 19.1;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify
Product Code: AQX-1125
INN or Proposed INN: AQX-1125
Other descriptive name: AQX-1125
Aquinox Pharmaceuticals (Canada) Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Germany;Latvia;Netherlands
24NCT03008382
(ClinicalTrials.gov)
March 1, 201728/12/2016Interstitial Cystitis: Examination of the Central Autonomic NetworkInterstitial Cystitis: Examination of the Central Autonomic NetworkInterstitial Cystitis/Painful Bladder Syndrome;Myofascial Pelvic PainDrug: Metoprolol Tartrate Oral Tablet;Drug: Placebo Oral TabletMedical College of WisconsinNorthShore University HealthSystem;Case Western Reserve UniversityActive, not recruiting18 Years80 YearsFemale180Phase 4United States
25EUCTR2016-000906-12-GB
(EUCTR)
23/11/201619/08/2016A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain SyndromeThe LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 19.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857
MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify
Product Code: AQX-1125
INN or Proposed INN: AQX-1125
Other descriptive name: AQX-1125
Aquinox Pharmaceuticals (Canada) Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Romania;Denmark;Netherlands;Latvia;United Kingdom
26EUCTR2016-000906-12-LV
(EUCTR)
11/11/201601/08/2016A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain SyndromeThe LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857
MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify
Product Code: AQX-1125
INN or Proposed INN: AQX-1125
Other descriptive name: AQX-1125
Aquinox Pharmaceuticals (Canada) Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Romania;Denmark;Netherlands;Latvia;United Kingdom
27EUCTR2016-000906-12-CZ
(EUCTR)
07/11/201627/07/2016A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain SyndromeThe LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857
MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify
Product Code: AQX-1125
INN or Proposed INN: AQX-1125
Other descriptive name: AQX-1125
Aquinox Pharmaceuticals (Canada) Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Romania;Denmark;Netherlands;Latvia;United Kingdom
28EUCTR2016-000906-12-HU
(EUCTR)
23/09/201627/07/2016The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by 14 or 40-Week Extension Periods - The LEADERSHIP 301 Trial The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by 14 or 40-Week Extension Periods - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 19.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857
MedDRA version: 19.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify
Product Code: AQX-1125
INN or Proposed INN: AQX-1125
Other descriptive name: AQX-1125
Aquinox Pharmaceuticals (Canada) Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Czech Republic;Hungary;Canada;Spain;Belgium;Poland;Romania;Denmark;Netherlands;Latvia;United Kingdom
29EUCTR2016-000906-12-DK
(EUCTR)
07/09/201619/07/2016A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain SyndromeThe LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857
MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify
Product Code: AQX-1125
INN or Proposed INN: AQX-1125
Other descriptive name: AQX-1125
Aquinox Pharmaceuticals (Canada) Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Romania;Denmark;Netherlands;Latvia;United Kingdom
30JPRN-UMIN000027918
2016/07/0125/06/2017Heparin-lidocaine intravesical injection therapy for refractory interstitial cystitis interstitial cystitisheparin-lidocaine intravesical therapyDepartment of Urology and Renal transplantation, Nagasaki University HospitalNULLRecruiting20years-old80years-oldMale and Female30Not selectedJapan
31JPRN-UMIN000026714
2016/02/2627/03/2017RCT study of bladder instillation therapy in patients with refractory interstitial cystitis. Interstitial cystitisTreated with vesical instillation with heparin and alkalized lidocaine. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.
Treated with vesical instillation with heparin alone. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.
Department of Urology, Mitsui Memorial HospitalNULLPending20years-oldNot applicableMale and Female20Phase 2,3Japan
32NCT01393223
(ClinicalTrials.gov)
July 21, 20157/7/2011Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder SyndromeA Single-Center, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 With Placebo in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)Interstitial CystitisDrug: LP-08 80mg;Drug: Normal saline;Drug: LP-08 20mgLipella Pharmaceuticals, Inc.William Beaumont HospitalsCompleted18 Years70 YearsAll21Phase 2United States
33JPRN-UMIN000014860
2014/10/3101/09/2014Efficacy and safety of intravesical administration of dimethyl sulfoxide (DMSO) in interstitial patientsEfficacy and safety of intravesical administration of dimethyl sulfoxide (DMSO) in interstitial patients - Efficacy and safety of intravesical administration of dimethyl sulfoxide (DMSO) in interstitial patients interstitial cystitisintravesical administration of DMSOUrology, Hokkaido University Graduate School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Not selectedJapan
34NCT02247557
(ClinicalTrials.gov)
September 201415/9/2014Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial CystitisIntravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis — a Randomized, Double-blind, Placebo-controlled, Prospective StudyInterstitial CystitisDrug: Liposome encapsulated BoNT-A;Drug: BOTOX 200U in normal saline;Drug: Normal salineBuddhist Tzu Chi General HospitalNULLCompleted20 Years80 YearsAll90Phase 2Taiwan
35JPRN-UMIN000009197
2014/07/0101/11/2012Safety and efficacy of tramadol in the treatment of refractory pain of interstitial cystitis: a double-blind, placebo-controlled, randomized prospective study interstitial cystitisoral administration of Tramadol after randomization
oral administration of placebo after randomization
Departmen of Urology, The University of Tokyo HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female90Not applicableJapan
36NCT01990898
(ClinicalTrials.gov)
November 201318/11/2013Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of ActionCyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of ActionInterstitial CystitisDrug: CyclosporineThe Cleveland ClinicNULLCompleted18 Years80 YearsAll26Phase 2United States
37EUCTR2011-004555-39-LT
(EUCTR)
10/05/201321/02/2013A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Germany;Latvia;Netherlands
38JPRN-JMA-IIA00113
27/02/201301/03/2013Multi-center clinical study on the effect of glycine for disorders of urine storageMulti-center clinical study on the effect of glycine for disorders of urine storage Overactive bladder, chronic prostatitis, interstitial cystitis, and nocturiaIntervention type:DRUG. Intervention1:glycine, Dose form:POWDER, Route of administration:ORAL, intended dose regimen:Oral administration of Glycine 3g, twice a day, for 8 weeks . Control intervention1:glucose, Dose form:POWDER, Route of administration:ORAL, Intended dose regimen:Oral administration of Glucose 3g, twice a day, for 8 weeks .Kimio Sugaya (Kitakami Central Hospital, and Southern Knights' Laboratory LLP)Okinawa Kyodo Hospital, Kawahara Nephro-urology Clinic, Yamada Urologic Clinic, Akita Urologic Clinic, Kobe Medical Center, Kitanodai Clinic, Yokohama Motimachi Womens' Clinic LUNA, Nanbu Tokushukai Hospital, Okinawa Kokubu HospitalCompleted>=20 YEARSNo LimitBOTH160NOT APPLICABLEJapan
39NCT01969773
(ClinicalTrials.gov)
December 201222/10/2013Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional TreatmentIntravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical TrialInterstitial CystitisDrug: Botulinum toxin A;Drug: Normal saline instillationBuddhist Tzu Chi General HospitalNULLCompleted20 Years85 YearsAll60Phase 2Taiwan
40JPRN-UMIN000008484
2012/07/2320/07/2012a Interstitial cystitis/ Hypersensitive bladder syndromeAdministration of mirabegron 50mg per day for four weeks.Department of Urology, Graduate school of medicine, University of TokyoNULLPending20years-oldNot applicableMale and Female20Not selectedJapan
41EUCTR2011-004555-39-NL
(EUCTR)
05/07/201208/02/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
INN or Proposed INN: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
INN or Proposed INN: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Netherlands;Germany;Latvia
42EUCTR2011-004555-39-PT
(EUCTR)
01/06/201205/03/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Germany;Latvia;Netherlands
43EUCTR2011-004555-39-PL
(EUCTR)
18/05/201211/04/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 16.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;Italy;France;Czech Republic;Poland;Belgium;Romania;Denmark;Netherlands;Germany;Latvia
44EUCTR2011-004555-39-BE
(EUCTR)
07/05/201219/01/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;Italy;France;Czech Republic;Belgium;Poland;Romania;Denmark;Germany;Latvia;Netherlands
45EUCTR2011-004555-39-DE
(EUCTR)
30/04/201222/02/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 16.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Germany;Netherlands;Latvia
46EUCTR2011-004555-39-ES
(EUCTR)
26/04/201206/03/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
300Phase 2Portugal;Russian Federation;Germany;Czech Republic;Netherlands;Denmark;Belgium;Romania;France;Spain;Latvia;Poland
47EUCTR2011-004555-39-LV
(EUCTR)
20/04/201201/03/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
300Phase 2Portugal;Germany;Netherlands;France;Italy;Latvia;Czech Republic;Russian Federation;Belgium;Denmark;Romania;Spain;Poland
48EUCTR2011-004555-39-DK
(EUCTR)
17/04/201217/04/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Belgium;Poland;Romania;Denmark;Germany;Latvia;Netherlands
49EUCTR2011-004555-39-CZ
(EUCTR)
13/04/201215/02/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 16.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Netherlands;Germany;Latvia
50JPRN-UMIN000006387
2011/11/0131/10/2011Clinical study on the intravesical instillation of heparin, lidocain and bicarbonate for the patients with interstitial cystitis interstitital cystitisIntravesical instillation of heparin, lidocain and bicarbonateUniversity of TokushimaNULLPendingNot applicableNot applicableMale and Female30Phase 2Japan
51NCT01475253
(ClinicalTrials.gov)
November 20113/11/2011Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial CystitisA Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label ExtensionInterstitial CystitisDrug: Lidocaine Releasing Intravesical System - LiRIS®;Other: LiRIS Placebo;Procedure: Sham Cystoscopy ProcedureAllerganTARIS Biomedical, Inc.Terminated18 YearsN/AFemale104Phase 2United States;Canada
52NCT05223244
(ClinicalTrials.gov)
October 1, 201124/1/2022Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed ICBladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis: a Prospective, Randomized TrialInterstitial Cystitis;Painful Bladder SyndromeDrug: bupivacaine, triamcinolone, and heparin (BTH);Drug: dimethyl sulfoxide (DMSO)NorthShore University HealthSystemNULLCompleted18 YearsN/AFemale83Phase 4NULL
53EUCTR2010-021556-25-IT
(EUCTR)
24/02/201104/11/2010Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)AscoltaTrascrizione foneticaDizionario - Visualizza dizionario dettagliato - IBSA 01-2010Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)AscoltaTrascrizione foneticaDizionario - Visualizza dizionario dettagliato - IBSA 01-2010 Interstitial Cystitis
MedDRA version: 9.1;Level: HLGT;Classification code 10018188
Trade Name: RIMSO 50
INN or Proposed INN: Dimethyl sulfoxide
IBSANULLNot RecruitingFemale: yes
Male: no
Phase 3Italy
54EUCTR2009-018118-21-CZ
(EUCTR)
09/08/201010/06/2010not applicableAn exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg
Product Code: OXN 5/2.5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 20mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release t
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: no
70Hungary;Czech Republic;Germany;United Kingdom
55EUCTR2009-018118-21-HU
(EUCTR)
04/08/201021/05/2010not applicableAn exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg
Product Code: OXN 5/2.5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 20mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release t
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: no
70Czech Republic;Hungary;Germany;United Kingdom
56EUCTR2009-018118-21-GB
(EUCTR)
28/07/201011/06/2010not applicableAn exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
MedDRA version: 14.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg
Product Code: OXN 5/2.5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 20mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10 mg PR
Mundipharma Research GmbH & Co. KGNULLNot Recruiting Female: yes
Male: no
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Hungary;Germany;United Kingdom
57NCT01150565
(ClinicalTrials.gov)
July 201023/6/2010Safety Study of LiRIS in Interstitial Cystitis (IC) PatientsPhase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial CystitisInterstitial CystitisDrug: LiRIS low dose and LiRIS high doseAllerganTARIS Biomedical, Inc.Completed18 YearsN/AFemale18Phase 1Canada
58EUCTR2009-014597-17-SE
(EUCTR)
03/05/201028/10/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Finland;Spain;Belgium;Germany;Sweden
59NCT01195116
(ClinicalTrials.gov)
May 201013/8/2010Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial CystitisUsefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial CystitisInterstitial CystitisDrug: Dexmedetomidine;Drug: Normal SalineUniversity of RochesterNULLCompleted18 YearsN/AAll41Phase 4United States
60EUCTR2009-014597-17-FI
(EUCTR)
24/03/201004/12/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Finland;Germany;Belgium;Spain;Sweden
61EUCTR2009-014597-17-DE
(EUCTR)
19/03/201003/12/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Finland;Germany;Belgium;Spain;Sweden
62EUCTR2009-014597-17-ES
(EUCTR)
08/02/201012/11/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)ESTUDIO EN FASE 2B, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE DETERMINACIÓN DE DOSIS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE TANEZUMAB EN EL TRATAMIENTO DEL DOLOR MODERADO A INTENSO ASOCIADO A CISTITIS INTERSTICIAL/SÍNDROME DE LA VEJIGA DOLOROSA (CI/SVD)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)ESTUDIO EN FASE 2B, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE DETERMINACIÓN DE DOSIS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE TANEZUMAB EN EL TRATAMIENTO DEL DOLOR MODERADO A INTENSO ASOCIADO A CISTITIS INTERSTICIAL/SÍNDROME DE LA VEJIGA DOLOROSA (CI/SVD) Tratamiento del dolor crónico incluyendo el dolor debido a cististis intersticial/síndrome de la vejiga dolorosa
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Finland;Belgium;Spain;Germany;Sweden
63EUCTR2009-014597-17-SK
(EUCTR)
03/02/201011/02/2010A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Slovakia;Finland;Spain;Belgium;Germany;Sweden
64NCT00823030
(ClinicalTrials.gov)
January 200914/1/2009Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial CystitisEffect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial CystitisInterstitial CystitisProcedure: Urodynamic study;Drug: Lidocaine;Other: Normal SalineNorth Shore Long Island Jewish Health SystemNULLWithdrawn18 Years80 YearsBoth0N/AUnited States
65EUCTR2008-002421-37-DK
(EUCTR)
13/11/200815/08/2008A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
MedDRA version: 9.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: PD 0299685
Product Name: PD 0299685
Pfizer Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
129Phase 2Finland;Germany;Denmark;France
66EUCTR2008-002421-37-FI
(EUCTR)
23/10/200802/09/2008A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
MedDRA version: 9.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: PD 0299685
Product Name: PD 0299685
Pfizer Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
129Phase 2Finland;Germany;Denmark;France
67EUCTR2008-002421-37-FR
(EUCTR)
07/10/200826/08/2008A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME (IC/PBS).
MedDRA version: 9.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: PD-0299685
Product Name: PD-0299685
Pfizer Ltd;Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
129Phase 2France;Finland;Denmark;Germany
68JPRN-UMIN000001253
2008/07/0116/07/2008A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis Interstitial cystitisThe patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 2 months (56days).
After that, the patients in hydrogen dissolution water group will be transferred to the additional intervention term after the end of intervention.
And after that, the patients will be randomized to withdrawal terms for more 1 month with hydrogen dissolution water or with placebo water.

The patients will be intervened with normal water (placebo group) 200ml every three times in a day in 2 months (56days)
After that, the patients in placebo water group will be given hydrogen water for more 1 month.
Koushinkai HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female30Phase 2,3Japan
69EUCTR2007-005164-27-NL
(EUCTR)
22/02/200817/10/2007Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/Interstitial CystitisBotulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/Interstitial Cystitis Interstitial Cystitis (IC) is a syndrome characterized by bladder pain associated with urgency, frequency, nocturia, dysuria and sterile urine. The patho-physiology remains largely unclear. No universally, effective, treatment exists. Botulinum toxin-A (BTX-A) inhibits the release of acetylcholine at the presynaptic cholinergic junction resulting in temporally muscle relaxation and bladder desensitisation. We explore the effects of intravesical injections with BTX-A in the treatment of IC.Trade Name: Botoxresearch office urology VUmcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Netherlands
70NCT00275379
(ClinicalTrials.gov)
August 20069/1/2006Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial CystitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial CystitisCystitis, InterstitialDrug: ERB-041Wyeth is now a wholly owned subsidiary of PfizerNULLWithdrawn18 YearsN/AFemale0N/AUnited States;Austria;Germany
71EUCTR2005-003367-23-DE
(EUCTR)
13/02/200623/11/2005A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not availableA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not available Interstitial Cystitis / Painful Bladder Syndrome
MedDRA version: 8.0;Level: LLT;Classification code 10008928
Product Name: YM672 (IPD®)
Product Code: YM672
INN or Proposed INN: Suplatast tosilate
Other descriptive name: IPD® (Japanese tradename)
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Germany;Sweden
72EUCTR2005-003367-23-DK
(EUCTR)
06/02/200621/12/2005A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not availableA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not available Interstitial Cystitis / Painful Bladder Syndrome
MedDRA version: 8.0;Level: LLT;Classification code 10008928
Trade Name: IPD® (suplatast tosilate)
Product Name: YM672 (IPD®)
Product Code: YM672
INN or Proposed INN: Suplatast tosilate
Other descriptive name: IPD® (Japanese tradename)
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Denmark;Germany;Sweden
73EUCTR2005-003367-23-SE
(EUCTR)
01/02/200606/12/2005A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not availableA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not available Interstitial Cystitis / Painful Bladder Syndrome
MedDRA version: 8.0;Level: LLT;Classification code 10008928
Trade Name: IPD® (suplatast tosilate)
Product Name: YM672 (IPD®)
Product Code: YM672
INN or Proposed INN: Suplatast tosilate
Other descriptive name: IPD® (Japanese tradename)
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Germany;Sweden
74NCT00253006
(ClinicalTrials.gov)
January 200611/11/2005Analysis of Expression of Nitric Oxide Syntheses and Their Functional Role in Human UrotheliumA Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human UrotheliumInterstitial Cystitis;Bladder Diseases;Urinary IncontinenceProcedure: Tissue examination for protein- and mRNA-expression of NOCopenhagen University Hospital at HerlevRoskilde County HospitalTerminated18 YearsN/ABoth60N/ADenmark
75EUCTR2005-000890-23-SE
(EUCTR)
13/10/200502/08/2005NO as an objective marker for inflammation in patients with interstitial cystitis treated with cyclosporine.NO as an objective marker for inflammation in patients with interstitial cystitis treated with cyclosporine. Interstitiell cystitTrade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
INN or Proposed INN: Ciklosporin
Ingrid EhrénNULLNot RecruitingFemale: yes
Male: yes
15Sweden
76JPRN-UMIN000003172
2005/05/0112/02/2010Clinacal study on the intravesical instillation of dimethylsulfoxide (DMSO) for the patients with interstitial cystitis Interstitial cystitisIntravesical instillation of DMSODeparment of Urology, Medical Science, University of FukuiNULLRecruitingNot applicableNot applicableMale and Female30Not applicableJapan
77JPRN-UMIN000027494
2004/07/2025/05/2017Intravesical administration of Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitisIntravesical administration of Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis - Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis Interstitial cystitisIntravesical DMSO administration (50%, 50ml),2weeks every, 8 timesDepartment of Urology, Hamamatsu University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not applicableJapan
78NCT00194610
(ClinicalTrials.gov)
May 200413/9/2005Botox as a Treatment for Interstitial Cystitis in WomenBotox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled TrialPainful Bladder Syndrome;Interstitial CystitisDrug: Botox;Other: normal salineUniversity of WashingtonPaul G. Allen Family FoundationCompleted18 YearsN/AFemale20Phase 4United States
79EUCTR2009-018118-21-DE
(EUCTR)
10/05/2010not applicableAn exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg
Product Code: OXN 5/2.5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 20mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release t
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: no
70Czech Republic;Hungary;Germany;United Kingdom
80EUCTR2008-002421-37-DE
(EUCTR)
29/07/2008A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
MedDRA version: 9.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: PD 0299685
Product Name: PD 0299685
Pfizer Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
147Phase 2Finland;Germany;Denmark;France