ASP6294 ( DrugBank: - )


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 : 143 薬物数 : 171 - (DrugBank : 56) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004138-12-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
2EUCTR2016-004138-12-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
3EUCTR2016-004138-12-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
4NCT03282318
(ClinicalTrials.gov)
September 28, 201712/9/2017A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial CystitisA 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 CystitisBladder Pain Syndrome;Interstitial CystitisDrug: ASP6294;Drug: PlaceboAstellas Pharma Europe B.V.NULLCompleted18 YearsN/AFemale119Phase 2Belgium;Czechia;Germany;Hungary;Latvia;Netherlands;Poland;Russian Federation;Spain;United Kingdom
5EUCTR2016-004138-12-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
6EUCTR2016-004138-12-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
7EUCTR2016-004138-12-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
8EUCTR2016-004138-12-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
9EUCTR2016-004138-12-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
10EUCTR2016-004138-12-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