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OpenTrials
Completed

NCT Number: NCT00290563

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

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

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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 Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MK0594

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. The incidence of dry mouth.

    Time frame: Duration of Treatment

    The incidence of dry mouth.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Vyne Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 13, 2006
Registry last updated
May 19, 2021

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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