Clinical trial NCT06285214: Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome
Official title: Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Interstitial Cystitis/Bladder Pain Syndrome
Lead sponsor: Imbrium Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Purdue Pharma LP
First posted: 2024-02-29
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria include:

1. Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
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.

Key Exclusion Criteria include:

1. Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator.
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.

Other protocol-specific inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline for bladder pain/discomfort scores over last 12 hours (morning and evening).
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
Secondary outcomes:
measure: Change from baseline in mean number of micturitions per 12 hours (morning and evening)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in Subject Global Response Assessment (SGRA)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in Symptom Impact Sleep Questionnaire (SISQ)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama, PC
state: Alabama
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Escondido
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
city: Los Angeles
country: United States
facility: Hope Clinical Research, LLC
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: DeLand
country: United States
facility: Accel Research Sites
state: Florida
city: Decatur
country: United States
facility: Accel Research Site - Neurostudies
state: Georgia
city: Evergreen Park
country: United States
facility: Providea Health Partners LLC
state: Illinois
city: Edgewood
country: United States
facility: Otrimed Clinical Research
state: Kentucky
city: Metairie
country: United States
facility: Southern Clinical Research Associates
state: Louisiana
city: Shreveport
country: United States
facility: Ochsner Louisiana State University Health Shreveport - Regional University
state: Louisiana
city: Owings Mills
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Dearborn Heights
country: United States
facility: Revive Research Institute, Inc
state: Michigan
city: Sartell
country: United States
facility: CentraCare - Urology Clinic
state: Minnesota
city: Omaha
country: United States
facility: Adult & Pediatric Urology P.C.
state: Nebraska
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice
state: New York
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research-Lyndhurst Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
Study officials:
References: