Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome
- Conditions
- Interstitial Cystitis/Bladder Pain Syndrome
- Interventions
- Drug: Placebo
- Registration Number
- NCT06285214
- Lead Sponsor
- Imbrium Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description V117957 V117957 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline for bladder pain/discomfort scores over last 12 hours (morning and evening). Baseline, Weeks 2, 4, 6, 8, and 9 Each evening and morning the subject will respond to the question "Please indicate the worst bladder pain/discomfort you have had overnight/over the day" using an 11-point NRS that ranges from 0= "no bladder pain/discomfort" to 10= "as bad as you can imagine bladder pain/discomfort."
- Secondary Outcome Measures
Name Time Method Change from baseline in mean number of micturitions per 12 hours (morning and evening) Baseline, Weeks 2, 4, 6, 8, and 9 Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS) Baseline, Weeks 2, 4, 6, 8, and 9 The BPIC-SS contains 8 questions concerning bladder pain over the previous 7 days. Questions 1-5 assess how often subject urinated because of pain, needed to urinate just after a previous urination, urinated to avoid pain, had pressure in their bladder, and had pain in their bladder, are rated on a 5-point scale from 1= "never" to 5= "always." Question 6 and 7 assess how bothered the subject was by frequent urination during daytime and during the night, rated on a 5-point scale from 1= "not at all" to 5= "a great deal." Question 8 assesses subject's worst bladder pain in past 7 days, rated on an 11-point NRS with range 0= "no bladder pain" to 10= "worst possible bladder pain." The BPIC-SS total score is the sum of the individual question scores and range from 0 to 38 with higher scores indicating a worse situation; a score of ≥19 may represent moderate/severe disease activity.
Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS) Baseline, Weeks 2, 4, 6, 8, and 9 The PPIUS is a 5-point scale designed for measurement of both urinary urgency and urge incontinence. Subjects are asked to indicate their micturition episode type (urinated= passed urine in the toilet, incontinence= involuntary release of urine) and then rate the episode urgency on a 5-point scale (0= no urgency, 1= mild urgency, 2= moderate urgency, 3= severe urgency, 4= urge incontinence).
Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Baseline, Weeks 2, 4, 6, 8, and 9 The ICPI contains 4 questions that assesses and how much of a problem the symptoms cause for the subject. Each question is rated using a 5-point scale. Total scores range from 0 to 16.
Change from baseline in Subject Global Response Assessment (SGRA) Baseline, Weeks 2, 4, 6, 8, and 9 The SGRA is a self-rated balanced measure of subject's clinical condition relative to baseline. There is 1 question: "Compared to your last visit, how would you rate your overall overactive bladder symptoms now?" A 7-point rating scale is used: 1= "markedly worse", 2= "moderately worse", 3= "slightly worse", 4= "no change", 5= "slightly improved", 6= "moderately improved" or 7= "markedly improved".
Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Baseline, Weeks 2, 4, 6, 8, and 9 The ICSI contains 4 questions that measure urgency and frequency of urination, nighttime urination, and pain or burning. Each question is rated using a 6- or 5-point scale. Total scores range from 0 to 21.
Change from baseline in Symptom Impact Sleep Questionnaire (SISQ) Baseline, Weeks 2, 4, 6, 8, and 9 The SISQ contains 2 questions that assess the quality of sleep and the impact of the subject's symptoms of IC/BPS on sleep and is to be completed each morning.
Trial Locations
- Locations (24)
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
Accel Research Sites
🇺🇸DeLand, Florida, United States
Tri Valley Urology Medical Group
🇺🇸Murrieta, California, 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
MidLantic Urology
🇺🇸Bala-Cynwyd, Pennsylvania, United States
MetroHealth System
🇺🇸Cleveland, Ohio, United States