Study of V117957 in Overactive Bladder Syndrome

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imbrium Therapeutics
• Collaborator: Purdue Pharma LP

Criteria

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.