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

May 18, 2021 updated by: Vyne Therapeutics Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

557

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
Time Frame: Duration of Trial
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
Duration of Trial

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vyne Therapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

September 24, 2007

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0594-003
  • MK0594-003
  • 2005_102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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