Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome
NCT ID: NCT06285214
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
47 participants
INTERVENTIONAL
2022-05-26
2025-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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V117957
V117957
V117957 1 mg - 1 tablet taken orally at bedtime.
Placebo
Placebo
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
Interventions
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V117957
V117957 1 mg - 1 tablet taken orally at bedtime.
Placebo
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes".
3. Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9.
4. Has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. Any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility.
Exclusion Criteria
2. Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI.
3. Hematuria determined to be associated with bladder malignancy or other significant pathology.
4. Had surgical procedure at any time that affected bladder function.
5. Received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. A subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology.
6. Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis.
18 Years
FEMALE
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Imbrium Therapeutics
INDUSTRY
Responsible Party
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Locations
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Urology Centers of Alabama, PC
Homewood, Alabama, United States
Urological Associates of Southern Arizona
Tucson, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Investigational Site
Escondido, California, United States
Urology Group of Southern California
Los Angeles, California, United States
Hope Clinical Research, LLC
Los Angeles, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
Accel Research Sites
DeLand, Florida, United States
Accel Research Site - Neurostudies
Decatur, Georgia, United States
Providea Health Partners LLC
Evergreen Park, Illinois, United States
Otrimed Clinical Research
Edgewood, Kentucky, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Ochsner Louisiana State University Health Shreveport - Regional University
Shreveport, Louisiana, United States
Chesapeake Urology Research Associates
Owings Mills, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Revive Research Institute, Inc
Dearborn Heights, Michigan, United States
CentraCare - Urology Clinic
Sartell, Minnesota, United States
Adult & Pediatric Urology P.C.
Omaha, Nebraska, United States
AccuMed Research Associates
Garden City, New York, United States
Manhattan Medical Research Practice
New York, New York, United States
Unified Women's Clinical Research-Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
MetroHealth System
Cleveland, Ohio, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Countries
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Other Identifiers
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OAG1050
Identifier Type: -
Identifier Source: org_study_id
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