Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2022-06-30
2024-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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V117957
V117957
V117957 1 mg - 1 tablet taken orally at bedtime.
Placebo
Placebo
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.
Placebo
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Imbrium Therapeutics
INDUSTRY
Responsible Party
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Locations
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Arizona Urology Specialists, PLLC
Tucson, Arizona, United States
Hope Clinical Research, LLC
Canoga Park, California, United States
ARK Clinical Research
Long Beach, California, United States
Urology Group of Southern California
Los Angeles, California, United States
Providea Health Partners, LLC
Evergreen Park, Illinois, United States
DelRicht Research
New Orleans, Louisiana, United States
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
AccuMed Research Associates
Garden City, New York, United States
Unified Women's Clinical Research-Lyndhurst
Winston-Salem, North Carolina, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OAG1030
Identifier Type: -
Identifier Source: org_study_id
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