Status:
COMPLETED
Study of V117957 in Overactive Bladder Syndrome
Lead Sponsor:
Imbrium Therapeutics
Collaborating Sponsors:
Purdue Pharma LP
Conditions:
Overactive Bladder Syndrome
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06024642
Start Date
June 30 2022
End Date
May 21 2024
Last Update
June 26 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Urology Specialists, PLLC
Tucson, Arizona, United States, 85715
2
Hope Clinical Research, LLC
Canoga Park, California, United States, 91303
3
ARK Clinical Research
Long Beach, California, United States, 90815
4
Urology Group of Southern California
Los Angeles, California, United States, 90017