226. 間質性膀胱炎(ハンナ型) [臨床試験数:133,薬物数:151(DrugBank:46),標的遺伝子数:48,標的パスウェイ数:137

Searched query = "Interstitial cystitis with Hunners ulcer", "Interstitial cystitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
86 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04349930January 202113/4/2020The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)Interstitial Cystitis;Bladder Pain SyndromeDrug: Cannabidiol vaginal suppository;Drug: Placebo vaginal suppositoryUniversity of New MexicoNULLNot yet recruiting18 YearsN/AFemale50Phase 1United States
2NCT04450316October 8, 202024/6/2020Low-dose Naltrexone for Bladder Pain SyndromeLow-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot TrialBladder Pain Syndrome;Interstitial CystitisDrug: Naltrexone;Drug: PlaceboStanford UniversityNULLRecruiting18 YearsN/AAll40Phase 2United States
3NCT04313972September 15, 202016/3/2020IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone, a Randomized Placebo-controlled Prospective TrialIC 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 HealthSystemNULLNot yet recruiting18 Years110 YearsFemale44Phase 4NULL
4NCT04208087March 30, 202025/11/2019PK and Safety of SI-722 in IC/BPSA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of SI-722 Intravesical Instillation in Interstitial Cystitis/Bladder Pain Syndrome SubjectsInterstitial Cystitis;Bladder Pain SyndromeDrug: SI-722;Drug: PlaceboSeikagaku CorporationNULLRecruiting18 Years80 YearsAll32Phase 1/Phase 2United States
5NCT03844412November 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-004138-12-BE27/11/201719/07/2017Study 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]
Astellas Pharma Europe B.V.NULLNot Recruiting Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noHungary;Czech Republic;Poland;Spain;Belgium;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
7EUCTR2016-004138-12-GB30/10/201717/07/2017Study 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]
Astellas Pharma Europe B.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noHungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
8EUCTR2016-004138-12-NL23/10/201724/07/2017Study 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]
Astellas Pharma Europe B.V.NULLNot Recruiting Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noHungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Latvia;Germany;Netherlands;United Kingdom
9NCT03282318September 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
10EUCTR2016-004138-12-PL27/09/201719/07/2017Study 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: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-004138-12-DE26/09/201710/07/2017Study 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]
Astellas Pharma Europe B.V.NULLNot Recruiting Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noHungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
12EUCTR2016-004138-12-ES18/09/201718/09/2017Study 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: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem 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
13EUCTR2016-004138-12-HU14/09/201712/07/2017Study 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: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
163Phase 2Czech Republic;Hungary;Poland;Belgium;Spain;Russian Federation;Netherlands;Latvia;Germany;United Kingdom
14EUCTR2016-004138-12-CZ30/08/201713/07/2017Study 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: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem 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
15EUCTR2016-004138-12-LV04/08/201725/07/2017Study 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]
Astellas Pharma Europe B.V.NULLNot Recruiting Female: yes
Male: no
163 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noHungary;Czech Republic;Poland;Belgium;Spain;Russian Federation;Netherlands;Germany;Latvia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-000906-12-NL15/06/201719/07/2017A 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 Level: LLT Classification code 10008927 Term: Chronic interstitial cystitis System Organ Class: 100000004857 ;Therapeutic area: Not possible to specify
Aquinox Pharmaceuticals (Canada) Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Netherlands;Germany;Latvia
17JPRN-JapicCTI-17356625/5/201720/04/2017Phase III study of KRP-116DA Phase III, multicenter, randomized, double-blind, placebo controlled, parallel group study to assess the efficacy and safety of KRP-116D in Japanese patients with interstitial cystisis. Interstitial cystitis( IC )Intervention name : KRP-116D
INN of the intervention : dimethyl sulfoxide
Dosage And administration of the intervention : 50 mL intravesical instillation once every two weeks
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : 50 mL intravesical instillation once every two weeks
Kyorin Pharmaceutical Co.,LTDNULLcomplete20BOTH90Phase 3Japan
18EUCTR2016-000906-12-BE24/04/201716/01/2017A 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: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000017419
MedDRA version: 20.0Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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
19EUCTR2016-000906-12-ES02/03/201716/01/2017A 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: 19.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857
MedDRA version: 19.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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
20NCT03008382March 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 UniversityRecruiting18 Years80 YearsFemale180Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-000906-12-GB23/11/201619/08/2016A 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: 19.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857
MedDRA version: 20.0Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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
22EUCTR2016-000906-12-LV11/11/201601/08/2016A 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: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857
MedDRA version: 20.0Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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
23EUCTR2016-000906-12-CZ07/11/201627/07/2016A 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: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857
MedDRA version: 20.0Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Romania;Denmark;Netherlands;Latvia;United Kingdom
24EUCTR2016-000906-12-HU23/09/201627/07/2016A 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 14 or 40-Week Extension Periods - The LEADERSHIP 301 Trial Interstitial Cystitis/Bladder Pain Syndrome
MedDRA version: 19.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857
MedDRA version: 19.0Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Latvia;United Kingdom
25EUCTR2016-000906-12-DK07/09/201619/07/2016A 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: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857
MedDRA version: 20.0Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02787083August 201623/5/2016A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial CystitisA Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial CystitisCystitis, InterstitialDrug: Mirabegron;Drug: PlaceboPhiladelphia Urosurgical AssociatesAstellas Pharma Global Development, Inc.Terminated18 Years95 YearsFemale9Phase 3United States
27NCT02858453July 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
28NCT02497976December 15, 201510/7/2015Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial CystitisPilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial CystitisCystitis, InterstitialBiological: Certolizumab pegol;Drug: PlaceboICStudy, LLCUCB PharmaCompleted18 Years65 YearsFemale42Phase 3United States
29NCT02591199September 201528/10/2015Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain SyndromeA Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared With the Individual Components Lidocaine and Heparin in Subjects With Interstitial Cystitis/Bladder Pain SyndromeInterstitial Cystitis;Bladder Pain SyndromeDrug: URG101;Drug: Placebo;Drug: Lidocaine;Drug: HeparinUrigenNULLTerminated18 YearsN/AAll92Phase 2United States
30NCT01393223July 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT02395042April 15, 201517/3/2015A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's LesionsA Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis With Hunner's LesionsCystitis, Interstitial;UlcerDrug: LiRIS®;Drug: LiRIS PlaceboAllerganNULLCompleted18 YearsN/AFemale59Phase 2United States;Canada
32NCT02517996February 201523/2/2015Use of Preemptive Pudendal Nerve Block Prior to Hydrodistention for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)Use of Preemptive Pudendal Nerve Block Prior to Hydrodistension for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-blinded, Randomized Control TrialInterstitial Cystitis;Painful Bladder SyndromeDrug: Lidocaine;Drug: PlaceboJohns Hopkins UniversityNULLTerminated18 YearsN/AFemale18N/AUnited States
33NCT02247557September 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
34JPRN-UMIN0000091972014/07/0101/11/2012Safety 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 appl1cableJapan
35NCT01882543June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2011-004555-39-LT10/05/201321/02/2013A 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: 14.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem 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
37NCT01824303March 201331/3/2013Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial CystitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label ExtensionInterstitial CystitisDrug: LiRIS 400 mg;Other: LiRIS PlaceboAllerganTARIS Biomedical, Inc.Terminated18 YearsN/AFemale31Phase 2United States;Canada
38NCT01969773December 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
39EUCTR2011-004555-39-NL05/07/201208/02/2012A 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: 14.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem 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
40EUCTR2011-004555-39-PT01/06/201205/03/2012A 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: 14.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01613586May 31, 20125/6/2012A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)A 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 Patients With Bladder Pain Syndrome / Interstitial CystitisCystitis, Interstitial;Urinary Bladder Disease;Pain;Urologic DiseasesDrug: ASP3652;Drug: PlaceboAstellas Pharma Europe B.V.NULLCompleted18 YearsN/AFemale287Phase 2Belgium;Czechia;Denmark;Germany;Latvia;Lithuania;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Czech Republic
42EUCTR2011-004555-39-PL18/05/201211/04/2012A 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: 16.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem 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
43EUCTR2011-004555-39-BE07/05/201219/01/2012A 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: 14.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem 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
44EUCTR2011-004555-39-DE30/04/201222/02/2012A 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: 16.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem 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
45EUCTR2011-004555-39-ES26/04/201206/03/2012A 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: 14.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2011-004555-39-LV20/04/201201/03/2012A 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: 14.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem 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
47EUCTR2011-004555-39-DK17/04/201217/04/2012A 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: 14.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem 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
48NCT01569438April 13, 201230/3/2012The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)A Four-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)Bladder Pain SyndromeDrug: Gefapixant;Drug: PlaceboAfferent Pharmaceuticals, Inc.NULLTerminated18 Years80 YearsFemale107Phase 2United States
49EUCTR2011-004555-39-CZ13/04/201215/02/2012A 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: 16.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem 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
50NCT01475253November 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT01295814March 201114/2/2011Efficacy Study of Adalimumab to Treat Interstitial CystitisAn Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)Interstitial CystitisDrug: Adalimumab;Other: inactive drugICStudy, LLCAbbottCompleted18 Years65 YearsAll43Phase 3United States
52NCT01197261September 20107/9/2010OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)An 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-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome.Interstitial Cystitis;Painful Bladder Syndrome;PainDrug: Oxycodone naloxone prolonged release tablets;Drug: Placebo tabletsMundipharma Research GmbH & Co KGNULLCompleted18 YearsN/AFemale120Phase 2Czechia;Germany;Hungary;Poland;United Kingdom;Czech Republic
53EUCTR2009-018118-21-CZ09/08/201010/06/2010not 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: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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
54EUCTR2009-018118-21-HU04/08/201021/05/2010not 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: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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
55EUCTR2009-018118-21-GB28/07/201011/06/2010not 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]
Mundipharma Research GmbH & Co. KGNULLNot Recruiting Female: yes
Male: no
70 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noCzech Republic;Hungary;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2009-014597-17-SE03/05/201028/10/2009A 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: 12.0Level: LLTClassification code 10008927Term: 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
57NCT01060254April 6, 201029/1/2010A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder PainA Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Interstitial Cystitis/ Painful Bladder SyndromeCystitis, Interstitial;Urologic Diseases;Urinary Bladder Diseases;CystitisDrug: Placebo;Drug: JNJ-42160443Johnson & Johnson Pharmaceutical Research & Development, L.L.C.NULLTerminated18 Years80 YearsAll31Phase 2United States;Canada
58EUCTR2009-014597-17-FI24/03/201004/12/2009A 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: 12.0Level: LLTClassification code 10008927Term: 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
59EUCTR2009-014597-17-DE19/03/201003/12/2009A 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: 12.0Level: LLTClassification code 10008927Term: 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
60EUCTR2009-014597-17-ES08/02/201012/11/2009A 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: 12.0Level: LLTClassification code 10008927Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2009-014597-17-SK03/02/201011/02/2010A 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: 12.0Level: LLTClassification code 10008927Term: 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
62NCT00999518January 22, 201020/10/2009A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder SyndromeA 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).Cystitis, InterstitialBiological: Tanezumab;Other: PlaceboPfizerNULLTerminated18 YearsN/AAll205Phase 2United States;Belgium;Canada;Finland;Hong Kong;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Germany;India;South Africa
63EUCTR2009-014597-17-BE24/12/200909/11/2009A 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)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: 12.0Level: LLTClassification code 10008927Term: 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2Finland;Germany;Belgium;Spain;Sweden
64NCT01030640December 20099/12/2009Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is InjectedA Phase 1, Randomized, Double- Blind (Sponsor-Open), Placebo-Controlled Study To Examine The Density Of Intraepidermal Nerve Fibers After A Single Subcutaneous Administration Of Tanezumab In Healthy VolunteersOsteoarthritis Pain;Chronic Low Back Pain;Pain Due to Interstitial CystitisOther: placebo;Biological: tanezumabPfizerNULLCompleted18 Years55 YearsBoth28Phase 1United States
65NCT00919113July 200911/6/2009Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder SyndromeA Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder SyndromeInterstitial Cystitis;Painful Bladder SyndromeDrug: 2% sodium chondroitin sulfate;Drug: PlaceboWatson PharmaceuticalsNULLCompleted18 YearsN/AFemale98Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66ChiCTR-TRC-130039382009-06-012013-05-17Efficacy of daily low-dose sildenafil for treating interstitial cystitis: results of randomized, double-blind, placebo-controlled trialEfficacy of daily low-dose sildenafil for treating interstitial cystitis: results of randomized, double-blind, placebo-controlled trial interstitial cystitisgroup A:oral sildenafil;group B:oral placebo ;The First Af?liated Hospital of Wenzhou Medical CollegeNULLCompleted3555Bothgroup A:24;group B:24;China
67EUCTR2008-002421-37-DK13/11/200815/08/2008A 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: 9.1Level: LLTClassification code 10008927Term: 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
68EUCTR2008-002421-37-FI23/10/200802/09/2008A 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: 9.1Level: LLTClassification code 10008927Term: 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
69EUCTR2008-002421-37-FR07/10/200826/08/2008A 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: 9.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitis
Product Name: PD-0299685
Product Name: PD-0299685
Pfizer Ltd;Ramsgate Road,Sandwich,Kent CT13 9NJNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
129Phase 2Finland;Germany;Denmark;France
70NCT00739739August 200820/8/2008An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial CystitisA 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 SyndromeDrug: PD 0299685 at 15mg BID;Drug: PD 0299685 at 30mg BID;Drug: placebo for PD 0299685PfizerNULLCompleted18 YearsN/ABoth161Phase 2United States;Canada;Denmark;Finland;France;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71JPRN-UMIN0000012532008/07/0116/07/2008A 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
72NCT00601484March 200815/1/2008An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial CystitisA Phase 2, 16 Week, Multicenter, Randomized, Double Blind Placebo Controlled, Parallel Group Proof Of Concept Study Evaluating The Efficacy And Safety Of PF-04383119 For The Treatment Of Pain Associated With Interstitial CystitisCystitis, InterstitialDrug: PF-04383119;Drug: PlaceboPfizerNULLCompleted18 YearsN/ABoth65Phase 2United States
73NCT00517868August 200715/8/2007Study of URG101 in Painful Bladder Syndrome and Interstitial CystitisURG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.Painful Bladder Syndrome;Interstitial CystitisDrug: URG101;Drug: PlaceboUrigenNULLCompleted18 YearsN/AAll28Phase 2United States
74NCT00451867March 200723/3/2007A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . .A Randomized Multicenter Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Mycophenolate Mofetil (CellCept) for the Treatment of Refractory Interstitial Cystitis (IC)Interstitial Cystitis;Painful Bladder SyndromeDrug: Mycophenolate Mofetil;Drug: Mycofenolate Mofetil (MMF);Drug: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLTerminated18 YearsN/ABoth210Phase 3United States;Canada
75NCT00275379August 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2005-003367-23-DE13/02/200623/11/2005A 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: 8.0Level: LLTClassification 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
77EUCTR2005-003367-23-DK06/02/200621/12/2005A 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: 8.0Level: LLTClassification 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Denmark;Germany;Sweden
78EUCTR2005-003367-23-SE01/02/200606/12/2005A 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: 8.0Level: LLTClassification 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
79NCT00256542January 200617/11/2005Study of U101 for Bladder Pain and/or UrgencyA Phase II Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravesical Alkalinized Lidocaine-Heparin for the Symptoms of Pelvic Pain and/or Urgency of Bladder OriginPelvic Pain;Interstitial Cystitis;Bladder DiseasesDrug: Alkalinized Lidocaine-HeparinUrigenNULLCompleted18 YearsN/ABoth90Phase 2United States
80NCT00295854May 200522/2/2006Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial CystitisA Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial CystitisInterstitial CystitisDrug: MN-001 BID;Drug: MN-001;Drug: PlaceboMediciNovaNULLCompleted18 YearsN/AAll296Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00124306February 200513/7/2005Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)A Randomized Multicenter Clinical Trial to Evaluate the Efficacy of Amitriptyline for the Treatment of Painful Bladder Syndrome (PBS) in Newly Diagnosed PatientsBladder Diseases;Interstitial CystitisDrug: Amitriptyline;Other: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)University of PennsylvaniaCompleted18 YearsN/ABoth271Phase 3United States;Canada
82NCT00194610May 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
83NCT00086684September 20037/7/2004Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial CystitisRandomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial CystitisInterstitial CystitisDrug: Pentosan polysulfate sodium 100 mg;Drug: PlaceboJohnson & Johnson Pharmaceutical Research & Development, L.L.C.NULLTerminated18 YearsN/AAll369Phase 4United States;Canada
84NCT00004316June 199518/10/1999Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar VestibulitisInterstitial Cystitis;Vulvar DiseasesDrug: capsaicinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)University of PittsburghCompleted18 YearsN/AFemale139Phase 1/Phase 2NULL
85EUCTR2009-018118-21-DE10/05/2010not 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: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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agemin
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PhaseCountries
86EUCTR2008-002421-37-DE29/07/2008A 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: 9.1Level: LLTClassification code 10008927Term: 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