Study of V117957 in Overactive Bladder Syndrome

Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Drug: V117957; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Arizona Urology Specialists, PLLC
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, LLC
    • Long Beach, California, United States, 90815
      • ARK Clinical Research
    • Los Angeles, California, United States, 90017
      • Urology Group of Southern California
  • Illinois
    • Evergreen Park, Illinois, United States, 60805
      • Providea Health Partners, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
    • Shreveport, Louisiana, United States, 71106
      • Ochsner LSU Health Shreveport - Regional Urology
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Women's Clinical Research-Lyndhurst
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria include:

1. Female, age ≥18-70 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
2. Has symptoms of overactive bladder including (OAB) urinary urgency and urinary frequency with incontinence for ≥3 months.
3. Willing to modify current OAB treatment regimen.

Key Exclusion Criteria include:

1. Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor.
2. Urinary tract infection (UTI) within past 30 days, or history of recurrent UTI.
3. Hematuria associated with bladder malignancy or other significant pathology.
4. Had surgical procedure that affected bladder function.
5. Received intravesical therapy within past 12 months or had bladder hydrodistention within past 6 months.
6. Grade III/IV pelvic organ prolapse with/without cystocele or urethral diverticulum.
7. Clinically significant kidney disease or nephrolithiasis.

Other protocol-specific inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
Experimental: V117957	Drug: V117957; V117957 1 mg - 1 tablet taken orally at bedtime.; Other Names: Sunobinop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours.	Subjects were asked to record all micturition episode components into a daily electronic diary during the 3 to 7 days prior to each scheduled clinic visit.	Baseline, Weeks 2, and 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Patient Perception of Bladder Condition (PPBC)	The PPBC is a single item that assesses the patients' subjective impression of their current urinary problem.	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in Overactive Bladder Questionnaire: Long-Form, 1-week Recall (OAB-q LF)	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).	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in Subject Global Response Assessment (SGRA)	The SGRA is a self-rated balanced measure of subject's clinical condition relative to baseline.	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)	The PPIUS is a 5-point scale designed for measurement of both urinary urgency and urge incontinence.	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in Symptom Impact Sleep Questionnaire (SISQ)	The SISQ contains 2 questions that assess the quality of sleep and the impact of the subject's symptoms of OAB on sleep.	Baseline, Weeks 2, 4, 6, 8, and 9

Collaborators and Investigators

• Sponsor: Imbrium Therapeutics
• Collaborators: Purdue Pharma LP

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): May 21, 2024
• Study Completion (Actual): May 21, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Urinary Bladder Diseases; Syndrome; Urinary Bladder, Overactive
• Other Study ID Numbers: OAG1030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No