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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-0634 50 mg
MK-0634 125 mg
Placebo for MK-0634
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    MK-0634 50 mg

    MK-0634 125 mg

    MK-0634 375 mg

    Placebo

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days)
    Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)
    Proportion of participants with abnormal visual field test (Follow-up Study 007 only)

    Secondary Outcome Measures

    Change from baseline in the number of total incontinence episodes
    Number of urge-incontinence episodes
    Number of urgency episodes per day averaged over a diary card week (4 to 10 days)

    Full Information

    First Posted
    September 30, 2005
    Last Updated
    December 16, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00231790
    Brief Title
    A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)
    Official Title
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    September 2006 (Actual)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    848 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-0634 50 mg
    Arm Type
    Experimental
    Arm Description
    All participants will receive placebo for the 1 week prior to randomization
    Arm Title
    MK-0634 125 mg
    Arm Type
    Experimental
    Arm Description
    All participants will receive placebo for the 1 week prior to randomization
    Arm Title
    MK-0634 375 mg
    Arm Type
    Experimental
    Arm Description
    All participants will receive placebo for the 1 week prior to randomization
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    All participants will receive placebo for the 1 week prior to randomization
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0634 50 mg
    Other Intervention Name(s)
    L-000796568
    Intervention Description
    one capsule orally, once daily in morning
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0634 125 mg
    Other Intervention Name(s)
    L-000796568
    Intervention Description
    one or three capsules orally, once daily in morning
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for MK-0634
    Intervention Description
    one, two, three or four capsules orally once daily in morning
    Primary Outcome Measure Information:
    Title
    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
    Title
    Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)
    Time Frame
    Day 1 of Follow-up
    Title
    Proportion of participants with abnormal visual field test (Follow-up Study 007 only)
    Time Frame
    Day 1 of Follow-up
    Secondary Outcome Measure Information:
    Title
    Change from baseline in the number of total incontinence episodes
    Time Frame
    Baseline and Week 8
    Title
    Number of urge-incontinence episodes
    Time Frame
    Up to 8 weeks
    Title
    Number of urgency episodes per day averaged over a diary card week (4 to 10 days)
    Time Frame
    up to 8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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