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OpenTrials
Completed

NCT Number: NCT00350636

A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females and males, 18 years of older with overactive bladder symptoms

Exclusion criteria

  • Treatable conditions that may cause urinary incontinence
  • Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
  • The use of concomitant drugs that would confound the efficacy evaluation.
  • The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

Treatment and study plan

Oxybutynin topical gel

Drug

1 application daily to skin for 12 weeks

Other names: Oxybutynin

Placebo topical gel

Other

1 application daily to skin for 12 weeks

Other names: Placebo

Primary outcomes

  1. Baseline Average Number of Daily Incontinence Episodes

    Time frame: Baseline

    Average number of daily incontinence episodes at baseline

  2. Change From Baseline in Average Daily Number of Incontinence Episodes

    Time frame: Baseline to Week 12

    Change from Baseline to Week 12 in average daily number of incontinence episodes

Secondary outcomes

  1. Baseline Average Daily Urinary Frequency

    Time frame: Baseline

    Number of daily urinary voids

  2. Change From Baseline in Average Daily Urinary Frequency

    Time frame: Baseline to 12 weeks

    Change from baseline in average daily urinary frequency

  3. Baseline Average Urine Void Volume

    Time frame: Baseline

    Baseline average urine void volume

  4. Change From Baseline in Average Urine Void Volume

    Time frame: Change from Baseline to Week 12

    Change from baseline to Week 12 in average urine void volume

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 11, 2006
Registry last updated
May 10, 2010

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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