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

NCT ID: NCT00231790

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

848 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-0634 50 mg

All participants will receive placebo for the 1 week prior to randomization

Group Type EXPERIMENTAL

MK-0634 50 mg

Intervention Type DRUG

one capsule orally, once daily in morning

MK-0634 125 mg

All participants will receive placebo for the 1 week prior to randomization

Group Type EXPERIMENTAL

MK-0634 125 mg

Intervention Type DRUG

one or three capsules orally, once daily in morning

MK-0634 375 mg

All participants will receive placebo for the 1 week prior to randomization

Group Type EXPERIMENTAL

MK-0634 125 mg

Intervention Type DRUG

one or three capsules orally, once daily in morning

Placebo

All participants will receive placebo for the 1 week prior to randomization

Group Type PLACEBO_COMPARATOR

Placebo for MK-0634

Intervention Type DRUG

one, two, three or four capsules orally once daily in morning

Interventions

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MK-0634 50 mg

one capsule orally, once daily in morning

Intervention Type DRUG

MK-0634 125 mg

one or three capsules orally, once daily in morning

Intervention Type DRUG

Placebo for MK-0634

one, two, three or four capsules orally once daily in morning

Intervention Type DRUG

Other Intervention Names

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L-000796568 L-000796568

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Australia Ireland New Zealand South Africa United Kingdom United States

Other Identifiers

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2005_045

Identifier Type: -

Identifier Source: secondary_id

0634-007

Identifier Type: -

Identifier Source: org_study_id