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