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

Phase 2

Completed

• Conditions: Urinary Incontinence
• Interventions: Drug: MK-0634 50 mg; Drug: MK-0634 125 mg; Drug: Placebo for MK-0634

• Registration Number: NCT00231790
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Primary Completion: 2006-09
• Study Completion: 2006-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 848

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-0634 50 mg	MK-0634 50 mg	All participants will receive placebo for the 1 week prior to randomization
MK-0634 125 mg	MK-0634 125 mg	All participants will receive placebo for the 1 week prior to randomization
MK-0634 375 mg	MK-0634 125 mg	All participants will receive placebo for the 1 week prior to randomization
Placebo	Placebo for MK-0634	All participants will receive placebo for the 1 week prior to randomization

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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