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

December 16, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

848

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and Week 8
Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)
Time Frame: Day 1 of Follow-up
Day 1 of Follow-up
Proportion of participants with abnormal visual field test (Follow-up Study 007 only)
Time Frame: Day 1 of Follow-up
Day 1 of Follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0634-007
  • 2005_045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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