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

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ClinicalTrials.gov Identifier: NCT00231790
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

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

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  (Clinical Trial)
Actual Enrollment : 848 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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 ]
  2. Proportion of participants with abnormal retinal photography (Follow-up Study 007 only) [ Time Frame: Day 1 of Follow-up ]
  3. Proportion of participants with abnormal visual field test (Follow-up Study 007 only) [ Time Frame: Day 1 of Follow-up ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231790


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00231790     History of Changes
Other Study ID Numbers: 0634-007
2005_045
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases