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

Vyne Therapeutics Inc.557 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

557

Conditions

Urinary Incontinence Overactive Bladder

Interventions

MK0594DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in baseline in average daily micturitions as recorded on patient voiding diaries.

Time frame: Duration of Trial

Secondary Outcomes

The incidence of dry mouth.

Time frame: Duration of Treatment

Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.

Time frame: Duration of Treatment

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

Time frame: Duration of Treatment

Data from ClinicalTrials.gov

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