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

July 10, 2006
April 13, 2010
June 2006
May 2007   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00350636 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: Oxybutynin topical gel
    1 application daily to skin for 12 weeks
    Other Name: Oxybutynin
  • Other: Placebo topical gel
    1 application daily to skin for 12 weeks
    Other Name: Placebo
  • Experimental: Oxybutynin topical gel
    Oxybutynin topical gel
    Intervention: Drug: Oxybutynin topical gel
  • Placebo Comparator: Placebo topical gel
    placebo topical gel
    Intervention: Other: Placebo topical gel
Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. Epub 2009 Feb 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
789
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00350636
OG05009
No
Gary Hoel PhD, Executive Director, Watson
Watson Pharmaceuticals
Not Provided
Study Director: Kim Caramelli, MS Watson Pharmaceuticals
Watson Pharmaceuticals
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP