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

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00350636
First received: July 10, 2006
Last updated: April 13, 2010
Last verified: April 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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

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

Additional Information:
Drugs@FDA  This link exits the ClinicalTrials.gov site
Watson Pharma product webpage  This link exits the ClinicalTrials.gov site

Publications:

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
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Oxybutynin
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents

ClinicalTrials.gov processed this record on May 19, 2013