Study of V117957 in Overactive Bladder Syndrome

Study Overview
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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.

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

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Drug: V117957
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V117957<br> | Drug: V117957<br>* V117957 1 mg - 1 tablet taken orally at bedtime.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline in volume voided per 24 hours. |  | Baseline, Weeks 2, 4, 6, 8, and 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |