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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00231790
First received: September 30, 2005
Last updated: April 4, 2012
Last verified: April 2012
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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 April 16, 2014