nctId: NCT06285214 id: OAG1050 briefTitle: Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome overallStatus: RECRUITING date: 2022-05-26 date: 2026-06 date: 2026-06 date: 2024-02-29 date: 2024-04-18 name: Imbrium Therapeutics class: INDUSTRY name: Purdue Pharma LP briefSummary: The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo. conditions: Interstitial Cystitis/Bladder Pain Syndrome studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: V117957 name: Placebo measure: Change from baseline for bladder pain/discomfort scores over last 12 hours (morning and evening). measure: Change from baseline in mean number of micturitions per 12 hours (morning and evening) measure: Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS) measure: Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS) measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) measure: Change from baseline in Subject Global Response Assessment (SGRA) measure: Change from baseline in Symptom Impact Sleep Questionnaire (SISQ) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Urology Centers of Alabama, PC status: RECRUITING city: Homewood state: Alabama zip: 35209 country: United States name: Central Contact role: CONTACT lat: 33.47177 lon: -86.80082 facility: Urological Associates of Southern Arizona status: RECRUITING city: Tucson state: Arizona zip: 85715 country: United States name: Central Contact role: CONTACT lat: 32.22174 lon: -110.92648 facility: Applied Research Center of Arkansas status: RECRUITING city: Little Rock state: Arkansas zip: 72212 country: United States name: Central Contact role: CONTACT lat: 34.74648 lon: -92.28959 facility: Investigational Site status: RECRUITING city: Escondido state: California zip: 92025 country: United States name: Central Contact role: CONTACT lat: 33.11921 lon: -117.08642 facility: Urology Group of Southern California status: RECRUITING city: Los Angeles state: California zip: 90017 country: United States name: Central Contact role: CONTACT lat: 34.05223 lon: -118.24368 facility: Hope Clinical Research, LLC status: RECRUITING city: Los Angeles state: California zip: 91303 country: United States name: Central Contact role: CONTACT lat: 34.05223 lon: -118.24368 facility: Tri Valley Urology Medical Group status: RECRUITING city: Murrieta state: California zip: 92562 country: United States name: Central Contact role: CONTACT lat: 33.55391 lon: -117.21392 facility: Accel Research Sites status: RECRUITING city: DeLand state: Florida zip: 32720 country: United States name: Central Contact role: CONTACT lat: 29.02832 lon: -81.30312 facility: Accel Research Site - Neurostudies status: RECRUITING city: Decatur state: Georgia zip: 30033 country: United States name: Central Contact role: CONTACT lat: 33.77483 lon: -84.29631 facility: Providea Health Partners LLC status: RECRUITING city: Evergreen Park state: Illinois zip: 60805 country: United States name: Central Contact role: CONTACT lat: 41.72059 lon: -87.70172 facility: Otrimed Clinical Research status: TERMINATED city: Edgewood state: Kentucky zip: 41017 country: United States lat: 39.01867 lon: -84.58189 facility: Southern Clinical Research Associates status: RECRUITING city: Metairie state: Louisiana zip: 70001 country: United States name: Central Contact role: CONTACT lat: 29.98409 lon: -90.15285 facility: Boston Clinical Trials status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States name: Central Contact role: CONTACT lat: 42.35843 lon: -71.05977 facility: Bay State Clinical Trials, Inc. status: RECRUITING city: Watertown state: Massachusetts zip: 02472 country: United States name: Central Contact role: CONTACT lat: 42.37093 lon: -71.18283 facility: Revive Research Institute, Inc status: RECRUITING city: Dearborn Heights state: Michigan zip: 48127 country: United States name: Central Contact role: CONTACT lat: 42.33698 lon: -83.27326 facility: CentraCare - Urology Clinic status: TERMINATED city: Sartell state: Minnesota zip: 56377 country: United States lat: 45.62163 lon: -94.20694 facility: Adult & Pediatric Urology P.C. status: RECRUITING city: Omaha state: Nebraska zip: 68114 country: United States name: Central Contact role: CONTACT lat: 41.25626 lon: -95.94043 facility: Great Lakes Physician, PC status: WITHDRAWN city: Cheektowaga state: New York zip: 14225 country: United States lat: 42.90339 lon: -78.75475 facility: AccuMed Research Associates status: RECRUITING city: Garden City state: New York zip: 11530 country: United States name: Central Contact role: CONTACT lat: 40.72677 lon: -73.6343 facility: Manhattan Medical Research Practice status: TERMINATED city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Unified Women's Clinical Research-Lyndhurst Clinical Research status: RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States name: Central Contact role: CONTACT lat: 36.09986 lon: -80.24422 facility: The Lindner Research Center at The Christ Hospital status: WITHDRAWN city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: MidLantic Urology status: TERMINATED city: Bala-Cynwyd state: Pennsylvania zip: 19004 country: United States lat: 40.00761 lon: -75.23407 facility: Antria, Inc. status: WITHDRAWN city: Indiana state: Pennsylvania zip: 15701 country: United States lat: 40.62146 lon: -79.15253 facility: Epic Clinical Research status: RECRUITING city: Lewisville state: Texas zip: 75057 country: United States name: Central Contact role: CONTACT lat: 33.04623 lon: -96.99417 facility: Urology of Virginia, PLLC status: WITHDRAWN city: Virginia Beach state: Virginia zip: 23462 country: United States lat: 36.85293 lon: -75.97799 hasResults: False