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

This study has been completed.
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: July 10, 2006
Last updated: April 13, 2010
Last verified: April 2010
A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Condition Intervention Phase
Overactive Bladder
Drug: Oxybutynin topical gel
Other: Placebo topical gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Baseline Average Number of Daily Incontinence Episodes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Average number of daily incontinence episodes at baseline

  • Change From Baseline in Average Daily Number of Incontinence Episodes [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Change from Baseline to Week 12 in average daily number of incontinence episodes

Secondary Outcome Measures:
  • Baseline Average Daily Urinary Frequency [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Number of daily urinary voids

  • Change From Baseline in Average Daily Urinary Frequency [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in average daily urinary frequency

  • Baseline Average Urine Void Volume [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline average urine void volume

  • Change From Baseline in Average Urine Void Volume [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    Change from baseline to Week 12 in average urine void volume

Enrollment: 789
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxybutynin topical gel
Oxybutynin topical gel
Drug: Oxybutynin topical gel
1 application daily to skin for 12 weeks
Other Name: Oxybutynin
Placebo Comparator: Placebo topical gel
placebo topical gel
Other: Placebo topical gel
1 application daily to skin for 12 weeks
Other Name: Placebo


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00350636

  Show 63 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Study Director: Kim Caramelli, MS Watson Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Gary Hoel PhD, Executive Director, Watson
ClinicalTrials.gov Identifier: NCT00350636     History of Changes
Other Study ID Numbers: OG05009 
Study First Received: July 10, 2006
Results First Received: April 13, 2010
Last Updated: April 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
OAB, anticholineric, oxybutynin, urge urinary incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Mandelic Acids
Anti-Infective Agents
Anti-Infective Agents, Urinary
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Renal Agents
Urological Agents

ClinicalTrials.gov processed this record on May 26, 2016