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


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

  
No.TrialIDDate_
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PhaseCountries
1NCT05062902
(ClinicalTrials.gov)
January 1, 202316/9/2021A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain ManagementAn Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain ManagementInterstitial Cystitis;Chronic Pain;Pelvic Floor; Relaxation;Pelvic Floor DisordersDevice: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device;Drug: Botulinum NeurotoxinHillMed Inc.Baylor College of Medicine;University of HoustonNot yet recruiting18 Years60 YearsFemale46Early Phase 1United States
2NCT04734106
(ClinicalTrials.gov)
May 202227/1/2021Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial CystitisA Double-Blind, Placebo-Controlled Study to Establish the Safety and Efficacy of Super-Concentrated, Freeze-Dried Aloe Vera in the Management of the Symptoms of Interstitial CystitisInterstitial Cystitis;Chronic Interstitial Cystitis;Bladder Pain SyndromeDrug: Desert Harvest Aloe Vera Capsules;Other: Placebo CapsulesWake Forest University Health SciencesDesert HarvestNot yet recruiting18 YearsN/AAll100Early Phase 1United States
3NCT05147779
(ClinicalTrials.gov)
December 202129/11/2021Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial CystitisSafety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Peyronie's Disease, Erectile Dysfunction, and Interstitial CystitisErectile Dysfunction;Peyronie's Disease;Interstitial CystitisBiological: AlloRxThe Foundation for Orthopaedics and Regenerative MedicineNULLRecruitingN/AN/AAll20Phase 1Antigua and Barbuda
4JPRN-jRCTs051210106
13/10/202113/10/2021ESTOC studyThe Effect of Suplatast Tosilate for interstitial Cystitis: A randomized controlled open-label trial - ESTOC study Interstitial cystitis
bladder, inflammation, pain;D018856
Participants will be randomly assigned to splatast group or control group.
In splatast group, splatast tosilate capsule 100 mg (1 capsule at a time) will be orally administered 3 times a day between meals for 3 months. In control group, flavoxate hydrochloride tablets 200 mg (1 tablet at a time) will be orally administered 3 times a day between meals for 3 months.
Torimoto KazumasaFujimoto KiyohideRecruiting>= 20age oldNot applicableBoth100Phase 2Japan
5NCT04845217
(ClinicalTrials.gov)
September 15, 202129/3/2021Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain SyndromeEfficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain SyndromeInterstitial CystitisDrug: Peppermint oil;Drug: Coconut OilUniversity of LouisvilleIntegrative Therapeutics, Inc.Recruiting18 Years65 YearsFemale100Phase 1/Phase 2United States
6NCT04313972
(ClinicalTrials.gov)
September 7, 202116/3/2020IC PaIN Trial: Interstitial Cystitis Pain Improvement With NaltrexoneIC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone, the Effect of Low Dose Naltrexone on Symptoms and Pain of Patients With Interstitial Cystitis/Painful Bladder Syndrome a Randomized Placebo-controlled Prospective TrialInterstitial Cystitis;Painful Bladder Syndrome;Bladder Pain Syndrome;Low Dose Naltrexone;Low-dose Naltrexone;NaltrexoneDrug: low-dose naltrexone;Drug: Placebo oral tabletNorthShore University HealthSystemNULLRecruiting18 Years110 YearsFemale44Phase 4United States
7NCT05275647
(ClinicalTrials.gov)
May 18, 202113/1/2022Efficacy and Safety of Low Energy Shock Wave Plus BotulinumToxin A in Treating Patients With Interstitial CystitisTherapeutic Efficacy and Safety of Low Energy Shock Wave (LESW) Plus Botulinum Toxin A Instillation in Treatment of Patients With Interstitial Cystitis Refractory to Conventional Therapy - A Clinical and Immunohistochemistry StudyInterstitial CystitisDrug: BOTOX 100U in normal saline;Drug: Normal salineBuddhist Tzu Chi General HospitalMinistry of Science and Technology, Taiwan;Hualien Tzu Chi General HospitalRecruiting20 YearsN/AAll75Phase 2Taiwan
8NCT04349930
(ClinicalTrials.gov)
January 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 MexicoNULLWithdrawn18 YearsN/AFemale0Phase 1United States
9NCT04610359
(ClinicalTrials.gov)
October 20, 202019/10/2020Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial CystitisSafety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 StudyInterstitial Cystitis;Stem Cell Transplant;Mesenchymal Stem CellDrug: MR-MC-01Asan Medical CenterMIRAE CELL BIORecruiting20 YearsN/AFemale3Phase 1Korea, Republic of
10NCT04447729
(ClinicalTrials.gov)
October 15, 202010/6/2020A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain SyndromeA Multicenter, Open-label Pilot Study of the Efficacy and Safety of Fremanezumab for Treatment of Female Patients With Interstitial Cystitis-Bladder Pain SyndromeInterstitial CystitisDrug: fremanezumabTeva Branded Pharmaceutical Products R&D, Inc.NULLWithdrawn18 YearsN/AFemale0Phase 2NULL
11NCT04450316
(ClinicalTrials.gov)
October 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
12NCT04401176
(ClinicalTrials.gov)
September 15, 202019/5/2020Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain SyndromeA Randomized Trial of Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain SyndromeInterstitial Cystitis;Bladder Pain SyndromeDrug: Heparin & Alkalinized Lidocaine Bladder Instillation;Drug: Onabotulinum Toxin AWalter Reed National Military Medical CenterNULLRecruiting18 YearsN/AFemale58Phase 2United States
13NCT04208087
(ClinicalTrials.gov)
March 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 CorporationNULLCompleted18 Years80 YearsAll33Phase 1/Phase 2United States
14NCT04789135
(ClinicalTrials.gov)
March 20, 20201/3/2021Evaluation of Response to Use of Intravesical Ozone Gas in Interstitial Cystitis /Bladder Pain SyndromeEvaluation of Response to Use of Intravesical Ozone Gas in Interstitial Cystitis/Bladder Pain SyndromeInterstitial Cystitis, Chronic;Bladder Pain SyndromeDrug: OzoneAnhembi Morumbi UniversityNULLActive, not recruitingN/AN/AFemale50Phase 2Brazil
15NCT03844412
(ClinicalTrials.gov)
November 4, 201915/2/2019Vestibulodynia: Understanding Pathophysiology and Determining Appropriate TreatmentsVestibulodynia: Understanding Pathophysiology and Determining Appropriate TreatmentsVestibulodynia;Temporomandibular Disorder;Fibromyalgia Syndrome;Irritable Bowel Syndrome;Migraines;Tension Headache;Endometriosis;Interstitial Cystitis;Back Pain;Chronic Fatigue SyndromeDrug: 5% lidocaine/5 mg/ml 0.02% estradiol compound cream;Drug: Nortriptyline;Drug: Placebo cream;Drug: Placebo pillDuke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Recruiting18 Years50 YearsFemale400Phase 2United States
16NCT04821882
(ClinicalTrials.gov)
May 1, 201925/3/2021Intravesical Injection of Dextrose to Improve Lower Urinary Tract Symptoms Caused by Chronic CystitisIntravesical Injection of Dextrose to Improve Lower Urinary Tract Symptoms Caused by Chronic CystitisBladder Pain Syndrome;Interstitial CystitisDrug: DextroseNational Defense Medical Center, TaiwanNULLCompleted20 YearsN/AAll29N/ATaiwan
17NCT04118946
(ClinicalTrials.gov)
March 20, 20192/10/2019Platelet Enriched Plasma for Treatment of Interstitial CystitisIntra Vesical Instillation Versus Submucosal Injection of Platelet Enriched Plasma for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: A Randomized Controlled TrialInterstitial Cystitis;Bladder Pain Syndrome;Platelet Enriched PlasmaBiological: platelet enriched plasmaMansoura UniversityNULLRecruiting18 YearsN/AFemale33Phase 1/Phase 2Egypt
18NCT03463915
(ClinicalTrials.gov)
January 25, 201928/2/2018Clinical Trial Comparing Two Bladder Instillations for IC/BPSRandomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain SyndromeInterstitial Cystitis;Bladder Pain SyndromeDrug: Bladder instillation WITH triamcinolone acetonide;Drug: Bladder instillation WITHOUT triamcinolone acetonideOlivia Cardenas-Trowers, M.D.NULLCompleted18 YearsN/AFemale90Phase 3United States
19NCT03844581
(ClinicalTrials.gov)
January 1, 201915/2/2019Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial CystitisEffect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial CystitisInterstitial CystitisDevice: interferential current;Drug: Propiverine HydrochlorideCairo UniversityNULLCompleted25 Years40 YearsFemale40N/AEgypt
20EUCTR2016-004138-12-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
21NCT03143920
(ClinicalTrials.gov)
November 1, 20172/5/2017Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary BladderHyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder: A Feasibility TrialChronic Interstitial Cystitis;Painful Bladder Syndrome;Recurrent Urinary Tract InfectionCombination Product: Hyperbaric Oxygen Therapy-University of California, San DiegoNULLRecruiting35 Years70 YearsFemale40Early Phase 1United States
22EUCTR2016-004138-12-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
23EUCTR2016-004138-12-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
24JPRN-UMIN000029113
2017/10/1020/09/2017Clinical study on the effect of fermented buckwheat sprouts in patients with interstitial cystitis Patients with interstitial cystitisIngestion of test food including fermented buckwheat sprouts (12 weeks, 4 tablets / once a day)Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of ShizuokaKageyama Hospital (Shizuoka city)Nakamura Hospital (Beppu city)Pending20years-oldNot applicableMale and Female20Not selectedJapan
25NCT03282318
(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
26EUCTR2016-004138-12-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
27EUCTR2016-004138-12-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
28NCT03463499
(ClinicalTrials.gov)
September 22, 201725/2/2018The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome PatientsThe Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome PatientsInterstitial CystitisDrug: Hyaluronic Acid and Chondroitin SulfateSamsung Medical CenterNULLActive, not recruiting20 YearsN/AAll62N/AKorea, Republic of
29EUCTR2016-004138-12-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
30EUCTR2016-004138-12-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
31EUCTR2016-004138-12-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
32EUCTR2016-004138-12-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
33EUCTR2016-000906-12-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
34JPRN-JapicCTI-173566
25/5/201720/04/2017Phase 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
35EUCTR2016-000906-12-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
36NCT02870738
(ClinicalTrials.gov)
April 21, 201712/8/2016Bladder Directed vs. Pelvic Floor Therapy in IC/BPSComparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain SyndromeCystitis, Interstitial;Painful Bladder SyndromeProcedure: Pelvic Floor Physical Therapy;Drug: Bladder InstillationsWilliam Beaumont HospitalsBaylor College of MedicineRecruiting18 Years85 YearsFemale128Phase 2United States
37NCT03104361
(ClinicalTrials.gov)
April 20173/4/2017Platelet-Rich Plasma (PRP) Injection in Treatment of Interstitial CystitisIntravesical Injections of Platelet-Rich Plasma (PRP) in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Clinical TrialInterstitial CystitisBiological: Platelet-Rich PlasmaBuddhist Tzu Chi General HospitalNULLNot yet recruiting20 YearsN/AAll30Phase 1Taiwan
38EUCTR2016-000906-12-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
39NCT03008382
(ClinicalTrials.gov)
March 1, 201728/12/2016Interstitial Cystitis: Examination of the Central Autonomic NetworkInterstitial Cystitis: Examination of the Central Autonomic NetworkInterstitial Cystitis/Painful Bladder Syndrome;Myofascial Pelvic PainDrug: Metoprolol Tartrate Oral Tablet;Drug: Placebo Oral TabletMedical College of WisconsinNorthShore University HealthSystem;Case Western Reserve UniversityActive, not recruiting18 Years80 YearsFemale180Phase 4United States
40EUCTR2016-000906-12-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
41EUCTR2016-000906-12-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
42EUCTR2016-000906-12-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
43EUCTR2016-000906-12-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
44EUCTR2016-000906-12-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
45NCT02787083
(ClinicalTrials.gov)
August 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
46JPRN-UMIN000027918
2016/07/0125/06/2017Heparin-lidocaine intravesical injection therapy for refractory interstitial cystitis interstitial cystitisheparin-lidocaine intravesical therapyDepartment of Urology and Renal transplantation, Nagasaki University HospitalNULLRecruiting20years-old80years-oldMale and Female30Not selectedJapan
47NCT02858453
(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
48NCT03693001
(ClinicalTrials.gov)
June 1, 201628/9/2018HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia)Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With FibromyalgiaFibromyalgia;Interstitial CystitisDevice: Intermittent Exposure to Oxygen via Oro-Nasal MaskUniversity of South FloridaUniversity of PadovaCompleted18 YearsN/AAll12N/ANULL
49JPRN-UMIN000026714
2016/02/2627/03/2017RCT study of bladder instillation therapy in patients with refractory interstitial cystitis. Interstitial cystitisTreated with vesical instillation with heparin and alkalized lidocaine. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.
Treated with vesical instillation with heparin alone. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.
Department of Urology, Mitsui Memorial HospitalNULLPending20years-oldNot applicableMale and Female20Phase 2,3Japan
50NCT02497976
(ClinicalTrials.gov)
December 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
51EUCTR2015-004495-30-FI
(EUCTR)
14/12/201520/10/2015Safety of intravesical bladder instillations among patients with severe interstitial cystitisSafety of intravesical bladder instillations among patients with severe interstitial cystitis Interstitial cystitis and bladder pain syndrome
MedDRA version: 18.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 18.1;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Trade Name: SANDIMMUN
INN or Proposed INN: CICLOSPORIN
Oulu University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Finland
52NCT02591199
(ClinicalTrials.gov)
September 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
53NCT01393223
(ClinicalTrials.gov)
July 21, 20157/7/2011Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder SyndromeA Single-Center, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 With Placebo in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)Interstitial CystitisDrug: LP-08 80mg;Drug: Normal saline;Drug: LP-08 20mgLipella Pharmaceuticals, Inc.William Beaumont HospitalsCompleted18 Years70 YearsAll21Phase 2United States
54NCT02395042
(ClinicalTrials.gov)
April 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
55NCT03076762
(ClinicalTrials.gov)
March 20151/3/2017Comparative Study Suburothelial and Trigonal Botulinum Toxin A Injection in Treatment of Interstitial CystitisComparative Study of the Efficacy and Safety Between Suburothelial and Trigonal Intravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Randomized, Clinical TrialBladder Pain SyndromeDrug: intravesical onabotulinumtoxinA injectionBuddhist Tzu Chi General HospitalNULLRecruiting18 YearsN/AAll60Phase 2Taiwan
56NCT02517996
(ClinicalTrials.gov)
February 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
57NCT02297100
(ClinicalTrials.gov)
December 201430/9/2014Intravesicular Onabotulinumtoxin A in Interstitial CystitisThe Impact of Injection Location on the Efficacy of Intravesicular Onabotulinumtoxin A in Interstitial Cystitis--Phase 4Interstitial CystitisDrug: Onabotulinumtoxin A;Procedure: injections upper aspect of trigone of urinary bladder;Procedure: injections on posterior bladder wall excluding the trigoneWake Forest University Health SciencesAllerganCompleted18 Years80 YearsFemale27Phase 4United States
58JPRN-UMIN000014860
2014/10/3101/09/2014Efficacy and safety of intravesical administration of dimethyl sulfoxide (DMSO) in interstitial patientsEfficacy and safety of intravesical administration of dimethyl sulfoxide (DMSO) in interstitial patients - Efficacy and safety of intravesical administration of dimethyl sulfoxide (DMSO) in interstitial patients interstitial cystitisintravesical administration of DMSOUrology, Hokkaido University Graduate School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Not selectedJapan
59NCT02247557
(ClinicalTrials.gov)
September 201415/9/2014Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial CystitisIntravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis — a Randomized, Double-blind, Placebo-controlled, Prospective StudyInterstitial CystitisDrug: Liposome encapsulated BoNT-A;Drug: BOTOX 200U in normal saline;Drug: Normal salineBuddhist Tzu Chi General HospitalNULLCompleted20 Years80 YearsAll90Phase 2Taiwan
60JPRN-UMIN000009197
2014/07/0101/11/2012Safety and efficacy of tramadol in the treatment of refractory pain of interstitial cystitis: a double-blind, placebo-controlled, randomized prospective study interstitial cystitisoral administration of Tramadol after randomization
oral administration of placebo after randomization
Departmen of Urology, The University of Tokyo HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female90Not applicableJapan
61NCT01990898
(ClinicalTrials.gov)
November 201318/11/2013Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of ActionCyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of ActionInterstitial CystitisDrug: CyclosporineThe Cleveland ClinicNULLCompleted18 Years80 YearsAll26Phase 2United States
62NCT01879683
(ClinicalTrials.gov)
July 201310/6/2013A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's LesionsA Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial CystitisChronic Interstitial CystitisDrug: LiRIS® 400 mgAllerganTARIS Biomedical, Inc.Completed18 YearsN/AFemale10Phase 1United States
63NCT01882543
(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
64EUCTR2011-004555-39-LT
(EUCTR)
10/05/201321/02/2013A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Germany;Latvia;Netherlands
65NCT01813565
(ClinicalTrials.gov)
March 20, 201311/3/2013The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.Interstitial CystitisDrug: Hyaluronic acid/chondroitin sulfateAsan Medical CenterNULLTerminated20 YearsN/AAll15N/AKorea, Republic of
66NCT01824303
(ClinicalTrials.gov)
March 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
67JPRN-JMA-IIA00113
27/02/201301/03/2013Multi-center clinical study on the effect of glycine for disorders of urine storageMulti-center clinical study on the effect of glycine for disorders of urine storage Overactive bladder, chronic prostatitis, interstitial cystitis, and nocturiaIntervention type:DRUG. Intervention1:glycine, Dose form:POWDER, Route of administration:ORAL, intended dose regimen:Oral administration of Glycine 3g, twice a day, for 8 weeks . Control intervention1:glucose, Dose form:POWDER, Route of administration:ORAL, Intended dose regimen:Oral administration of Glucose 3g, twice a day, for 8 weeks .Kimio Sugaya (Kitakami Central Hospital, and Southern Knights' Laboratory LLP)Okinawa Kyodo Hospital, Kawahara Nephro-urology Clinic, Yamada Urologic Clinic, Akita Urologic Clinic, Kobe Medical Center, Kitanodai Clinic, Yokohama Motimachi Womens' Clinic LUNA, Nanbu Tokushukai Hospital, Okinawa Kokubu HospitalCompleted>=20 YEARSNo LimitBOTH160NOT APPLICABLEJapan
68NCT01048177
(ClinicalTrials.gov)
December 201211/1/2010A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized VulvodyniaA Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized VulvodyniaVulvodyniaDrug: Bladder instillation with heparin/ lidocaineScripps HealthNULLWithdrawn18 Years80 YearsFemale0Phase 2United States
69NCT01969773
(ClinicalTrials.gov)
December 201222/10/2013Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional TreatmentIntravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical TrialInterstitial CystitisDrug: Botulinum toxin A;Drug: Normal saline instillationBuddhist Tzu Chi General HospitalNULLCompleted20 Years85 YearsAll60Phase 2Taiwan
70NCT01678911
(ClinicalTrials.gov)
August 201231/8/2012Efficacy of Gralise® for Chronic Pelvic PainEfficacy of Gralise® for Chronic Pelvic PainIrritable Bowel Syndrome;Ulcerative Colitis;Interstitial Cystitis;Prostatitis;Pelvic PainDrug: GraliseShirley Ryan AbilityLabNULLTerminated18 YearsN/AAll11Phase 4United States
71JPRN-UMIN000008484
2012/07/2320/07/2012a Interstitial cystitis/ Hypersensitive bladder syndromeAdministration of mirabegron 50mg per day for four weeks.Department of Urology, Graduate school of medicine, University of TokyoNULLPending20years-oldNot applicableMale and Female20Not selectedJapan
72EUCTR2011-004555-39-NL
(EUCTR)
05/07/201208/02/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
INN or Proposed INN: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
INN or Proposed INN: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Netherlands;Germany;Latvia
73NCT01731470
(ClinicalTrials.gov)
July 201215/11/2012Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)Interstitial Cystitis;Pelvic PainBiological: LiposomesKenneth Peters, MDWilliam Beaumont HospitalsCompleted18 YearsN/AAll14N/AUnited States
74EUCTR2011-004555-39-PT
(EUCTR)
01/06/201205/03/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Germany;Latvia;Netherlands
75NCT01613586
(ClinicalTrials.gov)
May 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
76EUCTR2011-004555-39-PL
(EUCTR)
18/05/201211/04/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 16.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;Italy;France;Czech Republic;Poland;Belgium;Romania;Denmark;Netherlands;Germany;Latvia
77EUCTR2011-004555-39-BE
(EUCTR)
07/05/201219/01/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;Italy;France;Czech Republic;Belgium;Poland;Romania;Denmark;Germany;Latvia;Netherlands
78NCT02000401
(ClinicalTrials.gov)
May 201219/11/2013Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of PainTo Evaluate the Efficacy, Tolerability, and Safety of Intranasal Ketorolac Tromethamine (Sprix) as an Option for Acute (up to 5 Days) Pain Management Adult Interstitial Cystitis Patients Experiencing a Flare of PainInterstitial CystitisDrug: Ketorolac TromethamineCitrus Valley Medical Research, Inc.NULLCompleted18 Years64 YearsFemale15Phase 4United States
79EUCTR2011-004555-39-DE
(EUCTR)
30/04/201222/02/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 16.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Germany;Netherlands;Latvia
80EUCTR2011-004555-39-ES
(EUCTR)
26/04/201206/03/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
300Phase 2Portugal;Russian Federation;Germany;Czech Republic;Netherlands;Denmark;Belgium;Romania;France;Spain;Latvia;Poland
81EUCTR2011-004555-39-LV
(EUCTR)
20/04/201201/03/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
300Phase 2Portugal;Germany;Netherlands;France;Italy;Latvia;Czech Republic;Russian Federation;Belgium;Denmark;Romania;Spain;Poland
82EUCTR2011-004555-39-DK
(EUCTR)
17/04/201217/04/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Belgium;Poland;Romania;Denmark;Germany;Latvia;Netherlands
83NCT01569438
(ClinicalTrials.gov)
April 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
84EUCTR2011-004555-39-CZ
(EUCTR)
13/04/201215/02/2012A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 16.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 16.1;Classification code 10008928;Term: Chronic interstitial cystitis NOS;Classification code 10008927;Term: Chronic interstitial cystitis;Level: PT;Classification code 10011796;Term: Cystitis interstitial;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Product Name: ASP3652
Product Code: ASP3652
Other descriptive name: ASP3652
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: no
300Phase 2Portugal;Spain;Lithuania;Russian Federation;France;Czech Republic;Poland;Belgium;Romania;Denmark;Netherlands;Germany;Latvia
85NCT01559961
(ClinicalTrials.gov)
March 201215/3/2012Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain SyndromeA Phase I Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain SyndromeInterstitial CystitisDrug: TTI-1612Trillium Therapeutics Inc.NULLCompleted18 Years65 YearsFemale28Phase 1Canada
86JPRN-UMIN000006387
2011/11/0131/10/2011Clinical study on the intravesical instillation of heparin, lidocain and bicarbonate for the patients with interstitial cystitis interstitital cystitisIntravesical instillation of heparin, lidocain and bicarbonateUniversity of TokushimaNULLPendingNot applicableNot applicableMale and Female30Phase 2Japan
87NCT01475253
(ClinicalTrials.gov)
November 20113/11/2011Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial CystitisA Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label ExtensionInterstitial CystitisDrug: Lidocaine Releasing Intravesical System - LiRIS®;Other: LiRIS Placebo;Procedure: Sham Cystoscopy ProcedureAllerganTARIS Biomedical, Inc.Terminated18 YearsN/AFemale104Phase 2United States;Canada
88NCT05223244
(ClinicalTrials.gov)
October 1, 201124/1/2022Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed ICBladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis: a Prospective, Randomized TrialInterstitial Cystitis;Painful Bladder SyndromeDrug: bupivacaine, triamcinolone, and heparin (BTH);Drug: dimethyl sulfoxide (DMSO)NorthShore University HealthSystemNULLCompleted18 YearsN/AFemale83Phase 4NULL
89NCT01378754
(ClinicalTrials.gov)
June 20118/6/2011Evaluate The Effectiveness Of Fospropofol (Lusedra®) For Induction Of AnesthesiaA DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPYInterstitial CystitisDrug: Fospropofol (Lusedra®) 6.5;Drug: Fospropofol (Lusedra®) 10;Drug: Fospropofol (Lusedra®) 12Grace Shih, MDNULLWithdrawn18 Years65 YearsBoth0N/AUnited States
90NCT01295814
(ClinicalTrials.gov)
March 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
91EUCTR2010-021556-25-IT
(EUCTR)
24/02/201104/11/2010Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)AscoltaTrascrizione foneticaDizionario - Visualizza dizionario dettagliato - IBSA 01-2010Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)AscoltaTrascrizione foneticaDizionario - Visualizza dizionario dettagliato - IBSA 01-2010 Interstitial Cystitis
MedDRA version: 9.1;Level: HLGT;Classification code 10018188
Trade Name: RIMSO 50
INN or Proposed INN: Dimethyl sulfoxide
IBSANULLNot RecruitingFemale: yes
Male: no
Phase 3Italy
92NCT01197261
(ClinicalTrials.gov)
September 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
93EUCTR2009-018118-21-CZ
(EUCTR)
09/08/201010/06/2010not applicableAn exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg
Product Code: OXN 5/2.5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 20mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release t
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: no
70Hungary;Czech Republic;Germany;United Kingdom
94EUCTR2009-018118-21-HU
(EUCTR)
04/08/201021/05/2010not applicableAn exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg
Product Code: OXN 5/2.5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 20mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release t
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: no
70Czech Republic;Hungary;Germany;United Kingdom
95NCT01083979
(ClinicalTrials.gov)
August 20108/3/2010Intravesical Liposomes for Ulcerative CystitisIntravesical Liposomes for Ulcerative CystitisInterstitial CystitisDrug: LiposomesKenneth Peters, MDNULLCompleted20 YearsN/AAll1N/AUnited States
96EUCTR2009-018118-21-GB
(EUCTR)
28/07/201011/06/2010not applicableAn exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
MedDRA version: 14.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg
Product Code: OXN 5/2.5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 20mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10 mg PR
Mundipharma Research GmbH & Co. KGNULLNot Recruiting Female: yes
Male: no
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Hungary;Germany;United Kingdom
97NCT01150565
(ClinicalTrials.gov)
July 201023/6/2010Safety Study of LiRIS in Interstitial Cystitis (IC) PatientsPhase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial CystitisInterstitial CystitisDrug: LiRIS low dose and LiRIS high doseAllerganTARIS Biomedical, Inc.Completed18 YearsN/AFemale18Phase 1Canada
98NCT00919802
(ClinicalTrials.gov)
June 20109/6/2009Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial CystitisIntranasal Oxytocin for the Treatment of Pain Associated With Interstitial CystitisInterstitial CystitisDrug: Oxytocin;Other: Saline as a nasal sprayUniversity of Alabama at BirminghamNULLCompleted19 Years65 YearsAll25Phase 4United States
99EUCTR2009-014597-17-SE
(EUCTR)
03/05/201028/10/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Finland;Spain;Belgium;Germany;Sweden
100NCT01195116
(ClinicalTrials.gov)
May 201013/8/2010Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial CystitisUsefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial CystitisInterstitial CystitisDrug: Dexmedetomidine;Drug: Normal SalineUniversity of RochesterNULLCompleted18 YearsN/AAll41Phase 4United States
101NCT01060254
(ClinicalTrials.gov)
April 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
102EUCTR2009-014597-17-FI
(EUCTR)
24/03/201004/12/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Finland;Germany;Belgium;Spain;Sweden
103EUCTR2009-014597-17-DE
(EUCTR)
19/03/201003/12/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Finland;Germany;Belgium;Spain;Sweden
104EUCTR2009-014597-17-ES
(EUCTR)
08/02/201012/11/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)ESTUDIO EN FASE 2B, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE DETERMINACIÓN DE DOSIS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE TANEZUMAB EN EL TRATAMIENTO DEL DOLOR MODERADO A INTENSO ASOCIADO A CISTITIS INTERSTICIAL/SÍNDROME DE LA VEJIGA DOLOROSA (CI/SVD)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)ESTUDIO EN FASE 2B, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE DETERMINACIÓN DE DOSIS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE TANEZUMAB EN EL TRATAMIENTO DEL DOLOR MODERADO A INTENSO ASOCIADO A CISTITIS INTERSTICIAL/SÍNDROME DE LA VEJIGA DOLOROSA (CI/SVD) Tratamiento del dolor crónico incluyendo el dolor debido a cististis intersticial/síndrome de la vejiga dolorosa
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Finland;Belgium;Spain;Germany;Sweden
105EUCTR2009-014597-17-SK
(EUCTR)
03/02/201011/02/2010A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
MedDRA version: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Slovakia;Finland;Spain;Belgium;Germany;Sweden
106NCT01069263
(ClinicalTrials.gov)
February 201010/1/2010Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial CystitisComparison Between Hyperbaric Oxygen Therapy (HBOT) and Intravesical Dimethyl Sulfoxide (DMSO) Instillation for the Treatment of Interstitial Cystitis - a Prospective, Randomized Cross-over TrialInterstitial CystitisOther: Hyperbaric Oxygen Therapy;Drug: DMSOAssaf-Harofeh Medical CenterNULLRecruiting18 Years85 YearsBoth60N/AIsrael
107NCT00999518
(ClinicalTrials.gov)
January 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
108EUCTR2009-014597-17-BE
(EUCTR)
24/12/200909/11/2009A 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: 12.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Product Name: Tanezumab
Product Code: PF-04383119
INN or Proposed INN: Tanezumab
Other descriptive name: RN624, RI624
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2Finland;Germany;Belgium;Spain;Sweden
109NCT01074567
(ClinicalTrials.gov)
December 200923/2/2010DMSO Efficacy in IC/PBS Patients During and After TreatmentEfficacy of DMSO Cocktail Treatment in Interstitial Cystitis Patients During and After TreatmentCystitis, InterstitialDrug: DMSO cocktailAssaf-Harofeh Medical CenterNULLRecruiting18 YearsN/AFemale50N/AIsrael
110NCT01030640
(ClinicalTrials.gov)
December 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
111NCT01616992
(ClinicalTrials.gov)
September 20098/6/2012Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic Characteristics (ICEPAC) StudyInterstitial Cystitis: Elucidation of the Psychophysiologic and AutonomicInterstitial Cystitis/Painful Bladder Syndrome;Myofascial Pelvic PainDrug: BupivacaineCase Western Reserve UniversityNULLCompleted18 Years80 YearsFemale200N/AUnited States
112NCT00919113
(ClinicalTrials.gov)
July 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
113ChiCTR-TRC-13003938
2009-06-012013-05-17Efficacy 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
114NCT01294878
(ClinicalTrials.gov)
March 200911/2/2011Omalizumab in Interstitial Cystitis/Bladder Pain SyndromeExplorative Study on the Use of Omalizumab in Patients Suffering From Interstitial Cystitis/Painful Bladder SyndromeInterstitial Cystitis;Painful Bladder SyndromeDrug: omalizumabIRCCS Policlinico S. MatteoNULLCompleted18 YearsN/AFemale3Phase 3Italy
115NCT00823030
(ClinicalTrials.gov)
January 200914/1/2009Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial CystitisEffect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial CystitisInterstitial CystitisProcedure: Urodynamic study;Drug: Lidocaine;Other: Normal SalineNorth Shore Long Island Jewish Health SystemNULLWithdrawn18 Years80 YearsBoth0N/AUnited States
116EUCTR2008-002421-37-DK
(EUCTR)
13/11/200815/08/2008A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
MedDRA version: 9.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: PD 0299685
Product Name: PD 0299685
Pfizer Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
129Phase 2Finland;Germany;Denmark;France
117EUCTR2008-002421-37-FI
(EUCTR)
23/10/200802/09/2008A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
MedDRA version: 9.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: PD 0299685
Product Name: PD 0299685
Pfizer Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
129Phase 2Finland;Germany;Denmark;France
118EUCTR2008-002421-37-FR
(EUCTR)
07/10/200826/08/2008A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME (IC/PBS).
MedDRA version: 9.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: PD-0299685
Product Name: PD-0299685
Pfizer Ltd;Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
129Phase 2France;Finland;Denmark;Germany
119NCT00739739
(ClinicalTrials.gov)
August 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
120JPRN-UMIN000001253
2008/07/0116/07/2008A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis Interstitial cystitisThe patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 2 months (56days).
After that, the patients in hydrogen dissolution water group will be transferred to the additional intervention term after the end of intervention.
And after that, the patients will be randomized to withdrawal terms for more 1 month with hydrogen dissolution water or with placebo water.

The patients will be intervened with normal water (placebo group) 200ml every three times in a day in 2 months (56days)
After that, the patients in placebo water group will be given hydrogen water for more 1 month.
Koushinkai HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female30Phase 2,3Japan
121EUCTR2008-001501-42-FI
(EUCTR)
15/05/200818/03/2008Tacrolimus in the treatment of Painful Bladder Syndrome / Interstitial CystitisTacrolimus in the treatment of Painful Bladder Syndrome / Interstitial Cystitis Painful bladder syndrome / interstitial cystitis (PBS/IC)
MedDRA version: 1;Level: LLT;Classification code 10005063;Term:
Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Jukka SairanenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Finland
122NCT00601484
(ClinicalTrials.gov)
March 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
123EUCTR2007-005164-27-NL
(EUCTR)
22/02/200817/10/2007Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/Interstitial CystitisBotulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/Interstitial Cystitis Interstitial Cystitis (IC) is a syndrome characterized by bladder pain associated with urgency, frequency, nocturia, dysuria and sterile urine. The patho-physiology remains largely unclear. No universally, effective, treatment exists. Botulinum toxin-A (BTX-A) inhibits the release of acetylcholine at the presynaptic cholinergic junction resulting in temporally muscle relaxation and bladder desensitisation. We explore the effects of intravesical injections with BTX-A in the treatment of IC.Trade Name: Botoxresearch office urology VUmcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Netherlands
124NCT00517868
(ClinicalTrials.gov)
August 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
125NCT00451867
(ClinicalTrials.gov)
March 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
126NCT00380783
(ClinicalTrials.gov)
October 200622/9/2006Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial CystitisCystitis, InterstitialDrug: AGN 203818AllerganNULLTerminated18 YearsN/AFemale2Phase 2United States
127NCT00275379
(ClinicalTrials.gov)
August 20069/1/2006Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial CystitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial CystitisCystitis, InterstitialDrug: ERB-041Wyeth is now a wholly owned subsidiary of PfizerNULLWithdrawn18 YearsN/AFemale0N/AUnited States;Austria;Germany
128NCT00317070
(ClinicalTrials.gov)
April 200620/4/2006Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)A Randomized Controlled Trial to Evaluate the Efficacy and Tolerability of Intravesical Cocktail and Comparison With Intravesical Dimethyl Sulfoxide (DMSO) for the Treatment of Painful Bladder Syndrome Including Interstitial Cystitis (PBS/IC)Interstitial Cystitis;Bladder DiseasesDrug: dimethyl sulfoxide;Drug: IC CocktailCapital District Health Authority, CanadaNULLTerminated18 YearsN/ABoth10Phase 2Canada
129EUCTR2005-003367-23-DE
(EUCTR)
13/02/200623/11/2005A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not availableA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not available Interstitial Cystitis / Painful Bladder Syndrome
MedDRA version: 8.0;Level: LLT;Classification code 10008928
Product Name: YM672 (IPD®)
Product Code: YM672
INN or Proposed INN: Suplatast tosilate
Other descriptive name: IPD® (Japanese tradename)
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Germany;Sweden
130EUCTR2005-003367-23-DK
(EUCTR)
06/02/200621/12/2005A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not availableA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not available Interstitial Cystitis / Painful Bladder Syndrome
MedDRA version: 8.0;Level: LLT;Classification code 10008928
Trade Name: IPD® (suplatast tosilate)
Product Name: YM672 (IPD®)
Product Code: YM672
INN or Proposed INN: Suplatast tosilate
Other descriptive name: IPD® (Japanese tradename)
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Denmark;Germany;Sweden
131EUCTR2005-003367-23-SE
(EUCTR)
01/02/200606/12/2005A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not availableA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis - Not available Interstitial Cystitis / Painful Bladder Syndrome
MedDRA version: 8.0;Level: LLT;Classification code 10008928
Trade Name: IPD® (suplatast tosilate)
Product Name: YM672 (IPD®)
Product Code: YM672
INN or Proposed INN: Suplatast tosilate
Other descriptive name: IPD® (Japanese tradename)
Astellas Pharma Europe B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Germany;Sweden
132NCT00253006
(ClinicalTrials.gov)
January 200611/11/2005Analysis of Expression of Nitric Oxide Syntheses and Their Functional Role in Human UrotheliumA Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human UrotheliumInterstitial Cystitis;Bladder Diseases;Urinary IncontinenceProcedure: Tissue examination for protein- and mRNA-expression of NOCopenhagen University Hospital at HerlevRoskilde County HospitalTerminated18 YearsN/ABoth60N/ADenmark
133NCT00256542
(ClinicalTrials.gov)
January 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
134EUCTR2005-000890-23-SE
(EUCTR)
13/10/200502/08/2005NO as an objective marker for inflammation in patients with interstitial cystitis treated with cyclosporine.NO as an objective marker for inflammation in patients with interstitial cystitis treated with cyclosporine. Interstitiell cystitTrade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
INN or Proposed INN: Ciklosporin
Ingrid EhrénNULLNot RecruitingFemale: yes
Male: yes
15Sweden
135JPRN-UMIN000003172
2005/05/0112/02/2010Clinacal study on the intravesical instillation of dimethylsulfoxide (DMSO) for the patients with interstitial cystitis Interstitial cystitisIntravesical instillation of DMSODeparment of Urology, Medical Science, University of FukuiNULLRecruitingNot applicableNot applicableMale and Female30Not applicableJapan
136NCT00295854
(ClinicalTrials.gov)
May 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
137NCT00124306
(ClinicalTrials.gov)
February 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
138JPRN-UMIN000027494
2004/07/2025/05/2017Intravesical administration of Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitisIntravesical administration of Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis - Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis Interstitial cystitisIntravesical DMSO administration (50%, 50ml),2weeks every, 8 timesDepartment of Urology, Hamamatsu University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not applicableJapan
139NCT00194610
(ClinicalTrials.gov)
May 200413/9/2005Botox as a Treatment for Interstitial Cystitis in WomenBotox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled TrialPainful Bladder Syndrome;Interstitial CystitisDrug: Botox;Other: normal salineUniversity of WashingtonPaul G. Allen Family FoundationCompleted18 YearsN/AFemale20Phase 4United States
140NCT00086684
(ClinicalTrials.gov)
September 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
141NCT00004316
(ClinicalTrials.gov)
June 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
142EUCTR2008-002421-37-DE
(EUCTR)
29/07/2008A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
MedDRA version: 9.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis
Product Name: PD 0299685
Product Name: PD 0299685
Pfizer Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
147Phase 2Finland;Germany;Denmark;France
143EUCTR2009-018118-21-DE
(EUCTR)
10/05/2010not applicableAn exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg
Product Code: OXN 5/2.5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 20mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10 mg PR
Other descriptive name: OXYCODONE HYDROCHLORIDE
Other descriptive name: NALOXONE HYDROCHLORIDE
Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release t
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: no
70Czech Republic;Hungary;Germany;United Kingdom