Study of V117957 in 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.

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Key information

Conditions

Overactive Bladder Syndrome

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Urology Specialists, PLLC, Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria include:

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

Key Exclusion Criteria include:

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

Other protocol-specific inclusion and exclusion criteria may apply.

Treatment and study plan

V117957

Drug

V117957 1 mg - 1 tablet taken orally at bedtime.

Other names: Sunobinop

Placebo

Drug

Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.

Primary outcomes

Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours.

Time frame: Baseline, Weeks 2, and 8

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.

Sponsors and collaborators

Lead sponsor

Imbrium Therapeutics

Industry

Collaborators

Purdue Pharma LP

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Sep 6, 2023
Registry last updated: Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed