AQX-1125 ( DrugBank: AQX-1125 )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
226間質性膀胱炎(ハンナ型)10

226. 間質性膀胱炎(ハンナ型)


臨床試験数 : 145 薬物数 : 156 - (DrugBank : 51) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000906-12-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
2EUCTR2016-000906-12-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
3EUCTR2016-000906-12-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
4EUCTR2016-000906-12-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
5EUCTR2016-000906-12-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
6EUCTR2016-000906-12-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
7EUCTR2016-000906-12-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
8EUCTR2016-000906-12-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
9NCT02858453
(ClinicalTrials.gov)
July 201619/4/2016Efficacy and Safety of 2 Doses of AQX-1125 in 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 Src Homology 2-containing Inositol-5'-Phosphatase 1 (SHIP1) Pathway in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension PeriodInterstitial Cystitis;Bladder Pain Syndrome;Painful Bladder Syndrome;Chronic Interstitial CystitisDrug: AQX-1125 100 mg;Drug: AQX-1125 200 mg;Drug: PlaceboAquinox Pharmaceuticals (Canada) Inc.NULLUnknown status18 Years80 YearsAll433Phase 3United States;Belgium;Canada;Czechia;Denmark;Hungary;Latvia;Netherlands;Poland;Romania;Spain;United Kingdom;Czech Republic
10NCT01882543
(ClinicalTrials.gov)
June 201318/6/2013Efficacy and Safety of AQX-1125 in IC/BPSA Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] PathwayInterstitial Cystitis;Bladder Pain SyndromeDrug: AQX-1125;Drug: PlaceboAquinox Pharmaceuticals (Canada) Inc.NULLCompleted18 Years75 YearsFemale69Phase 2United States;Canada