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NCT00290563 Clinical Trial

Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)

Urinary Incontinence Clinical Trial

Official title:
A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK0594 in Patients With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00290563
Other study ID # 0594-003
Secondary ID MK0594-0032005_1
Status Completed
Phase Phase 2
First received
Last updated
Start date February 21, 2006
Est. completion date September 24, 2007

Study information
Verified date May 2021
Source Vyne Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.

Recruitment information / eligibility
Status Completed
Enrollment 557
Est. completion date September 24, 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender All
Age group 40 Years to 74 Years
Eligibility Inclusion Criteria: - Patients with predominantly urge incontinence overactive bladder episodes - Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards Exclusion Criteria: - History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia - Lower urinary tract symptoms associated with benign prostatic hypertrophy - Active or current Urinary Tract Infections (UTIs) - Surgery to correct prolapsed uterus or stress incontinence

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0594

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vyne Therapeutics Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Change in baseline in average daily micturitions as recorded on patient voiding diaries. Change in baseline in average daily micturitions as recorded on patient voiding diaries. Duration of Trial
Secondary The incidence of dry mouth. The incidence of dry mouth. Duration of Treatment
Secondary Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries. Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries. Duration of Treatment
Secondary Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms. Global assessment of improvement in UI, perception of urgency, and bother of UI Duration of Treatment
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