A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)

Study Overview
=================
Brief Summary
-----------------
Overactive bladder is very prevalent in postmenopausal women. The current study is designed to investigate whether a new drug may offer safe and effective treatment.

Detailed Description
-----------------
Clinical development of MK-0634 was discontinued. Study MK-0634-027 was a safety follow-up study to determine if there were any ocular effects of MK-0634 in participants from the United Kingdom who were exposed to MK-0634 during the 007 study.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: MK-0634 50 mg
* Drug: MK-0634 125 mg
* Drug: Placebo for MK-0634


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal females (ages 40-74) with predominantly urge urinary incontinence overactive bladder episodes. Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards. Exclusion Criteria: Patients must not suffer from diabetes insipidus Hyperglycemia Hypercalcemia Orthostatic hypotension Active/recurrent urinary tract infections (>6 episodes per year) Patients must be willing to discontinue their current OAB medication therapy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0634 50 mg<br>All participants will receive placebo for the 1 week prior to randomization | Drug: MK-0634 50 mg<br>* one capsule orally, once daily in morning<br>* Other names: L-000796568;|
| Experimental: MK-0634 125 mg<br>All participants will receive placebo for the 1 week prior to randomization | Drug: MK-0634 125 mg<br>* one or three capsules orally, once daily in morning<br>* Other names: L-000796568;|
| Experimental: MK-0634 375 mg<br>All participants will receive placebo for the 1 week prior to randomization | Drug: MK-0634 125 mg<br>* one or three capsules orally, once daily in morning<br>* Other names: L-000796568;|
| Placebo Comparator: Placebo<br>All participants will receive placebo for the 1 week prior to randomization | Drug: Placebo for MK-0634<br>* one, two, three or four capsules orally once daily in morning<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days) |  | Baseline and Week 8 | 
| Proportion of participants with abnormal retinal photography (Follow-up Study 007 only) |  | Day 1 of Follow-up | 
| Proportion of participants with abnormal visual field test (Follow-up Study 007 only) |  | Day 1 of Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of total incontinence episodes |  | Baseline and Week 8 | 
| Number of urge-incontinence episodes |  | Up to 8 weeks | 
| Number of urgency episodes per day averaged over a diary card week (4 to 10 days) |  | up to 8 weeks |