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

Phase 2

Completed

• Conditions: Urinary Incontinence; Overactive Bladder

• Registration Number: NCT00290563
• Lead Sponsor: Vyne Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-10
• Study First Submitted QC: 2006-02-10
• Study First Posted: 2006-02-13
• Study Start: 2006-02-21
• Primary Completion: 2007-08
• Study Completion: 2007-09-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 557

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in baseline in average daily micturitions as recorded on patient voiding diaries.	Duration of Trial	Change in baseline in average daily micturitions as recorded on patient voiding diaries.

Secondary Outcome Measures

Name	Time	Method
The incidence of dry mouth.	Duration of Treatment	The incidence of dry mouth.
Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.	Duration of Treatment	Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.
Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms.	Duration of Treatment	Global assessment of improvement in UI, perception of urgency, and bother of UI