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

Purpose

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.

Condition	Intervention	Phase
Urinary Incontinence	Drug: MK-0634 50 mg Drug: MK-0634 125 mg Drug: Placebo for MK-0634	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Proportion of participants with abnormal retinal photography (Follow-up Study 007 only) [ Time Frame: Day 1 of Follow-up ] [ Designated as safety issue: Yes ]
Proportion of participants with abnormal visual field test (Follow-up Study 007 only) [ Time Frame: Day 1 of Follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline in the number of total incontinence episodes [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Number of urge-incontinence episodes [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Number of urgency episodes per day averaged over a diary card week (4 to 10 days) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	848
Study Start Date:	September 2005
Study Completion Date:	September 2009
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MK-0634 50 mg All participants will receive placebo for the 1 week prior to randomization	Drug: MK-0634 50 mg one capsule orally, once daily in morning Other Name: L-000796568
Experimental: MK-0634 125 mg All participants will receive placebo for the 1 week prior to randomization	Drug: MK-0634 125 mg one or three capsules orally, once daily in morning Other Name: L-000796568
Experimental: MK-0634 375 mg All participants will receive placebo for the 1 week prior to randomization	Drug: MK-0634 125 mg one or three capsules orally, once daily in morning Other Name: L-000796568
Placebo Comparator: Placebo All participants will receive placebo for the 1 week prior to randomization	Drug: Placebo for MK-0634 one, two, three or four capsules orally once daily in morning

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.

Eligibility

Ages Eligible for Study:	40 Years to 74 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231790

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00231790 History of Changes
Other Study ID Numbers:	2005_045, MK0634-007 (027)
Study First Received:	September 30, 2005
Last Updated:	April 4, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases

Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 16, 2013