Study of V117957 in Overactive Bladder Syndrome

NCT ID: NCT06024642

Last Updated: 2025-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-05-21

Brief Summary

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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

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Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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V117957

Group Type EXPERIMENTAL

V117957

Intervention Type DRUG

V117957 1 mg - 1 tablet taken orally at bedtime.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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V117957

V117957 1 mg - 1 tablet taken orally at bedtime.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Sunobinop

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Purdue Pharma LP

INDUSTRY

Sponsor Role collaborator

Imbrium Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Urology Specialists, PLLC

Tucson, Arizona, United States

Site Status

Hope Clinical Research, LLC

Canoga Park, California, United States

Site Status

ARK Clinical Research

Long Beach, California, United States

Site Status

Urology Group of Southern California

Los Angeles, California, United States

Site Status

Providea Health Partners, LLC

Evergreen Park, Illinois, United States

Site Status

DelRicht Research

New Orleans, Louisiana, United States

Site Status

Ochsner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, United States

Site Status

Boston Clinical Trials

Boston, Massachusetts, United States

Site Status

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, United States

Site Status

AccuMed Research Associates

Garden City, New York, United States

Site Status

Unified Women's Clinical Research-Lyndhurst

Winston-Salem, North Carolina, United States

Site Status

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OAG1030

Identifier Type: -

Identifier Source: org_study_id

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