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Completed

NCT Number: NCT00231790

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-0634 50 mg

Drug

one capsule orally, once daily in morning

Other names: L-000796568

MK-0634 125 mg

Drug

one or three capsules orally, once daily in morning

Other names: L-000796568

Placebo for MK-0634

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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