Study of V117957 in Overactive Bladder Syndrome

Overactive Bladder Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06024642
• Other study ID #: OAG1030
• Status: Completed
• Phase: Phase 1
• Start date: June 30, 2022
• Est. completion date: May 21, 2024

Study information

• Verified date: June 2024
• Source: Imbrium Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 21, 2024
• Est. primary completion date: May 21, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• V117957
V117957 1 mg - 1 tablet taken orally at bedtime.
• Placebo
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Imbrium Therapeutics	Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline in volume voided per 24 hours.		Baseline, Weeks 2, 4, 6, 8, and 9
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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