Study of V117957 in Overactive Bladder Syndrome
- Registration Number
- NCT06024642
- Lead Sponsor
- Imbrium Therapeutics
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 51
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 in number of micturition episodes per 24 hours and number of incontinence episodes per 24 hours. Baseline, Weeks 2, 4, 6, 8, and 9 Change from baseline in volume voided per 24 hours. Baseline, Weeks 2, 4, 6, 8, and 9
- Secondary Outcome Measures
Name Time Method Change from baseline in Overactive Bladder Questionnaire: Long-Form, 1-week Recall (OAB-q LF) Baseline, Weeks 2, 4, 6, 8, and 9 The OAB-q LF is a 33-item, condition-specific measure designed to assess the impact of OAB symptoms on Health-related Quality of Life (HRQL).
Change from baseline in Patient Perception of Bladder Condition (PPBC) Baseline, Weeks 2, 4, 6, 8, and 9 The PPBC is a single item that assesses the patients' subjective impression of their current urinary problem.
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.
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.
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 OAB on sleep.
Trial Locations
- Locations (12)
Bay State Clinical Trials, Inc.
🇺🇸Watertown, Massachusetts, United States
Arizona Urology Specialists, PLLC
🇺🇸Tucson, Arizona, United States
Providea Health Partners, LLC
🇺🇸Evergreen Park, Illinois, United States
Hope Clinical Research, LLC
🇺🇸Canoga Park, California, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
ARK Clinical Research
🇺🇸Long Beach, California, United States
Ochsner LSU Health Shreveport - Regional Urology
🇺🇸Shreveport, Louisiana, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Urology Group of Southern California
🇺🇸Los Angeles, California, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Unified Women's Clinical Research-Lyndhurst
🇺🇸Winston-Salem, North Carolina, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States