Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00196404
First received: September 13, 2005
Last updated: August 17, 2012
Last verified: August 2012

September 13, 2005
August 17, 2012
October 2004
December 2006   (final data collection date for primary outcome measure)
Change in the total weekly number of incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
Change in the total weekly number of incontinence episodes
Complete list of historical versions of study NCT00196404 on ClinicalTrials.gov Archive Site
  • Average daily urinary frequency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
  • Proportion of patients with no incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
  • Average void volume [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
  • Average severity of urgency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
  • Average daily urinary frequency
  • Proportion of patients with no incontinence episodes
  • Average void volume
  • Average severity of urgency
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Urinary Incontinence
  • Drug: DR-3001a
    4mg daily vaginally
  • Drug: DR-3001b
    6 mg vaginally daily
  • Other: Placebo
    Administered vaginally to match experimental arms
  • Experimental: 1
    Intervention: Drug: DR-3001a
  • Experimental: 2
    Intervention: Drug: DR-3001b
  • Placebo Comparator: 3
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of overactive bladder and incontinence for at least 6 months
  • Using birth control or menopausal
  • Willing to discontinue current medication for overactive bladder

Exclusion Criteria:

  • Pregnant or given birth in the last 6 months
  • Three or more urinary tract infections a year
  • Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
  • History of bladder cancer, ulcerative colitis or severe constipation
  • Any contraindication to vaginal delivery systems
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00196404
BR-OXY-202
No
Duramed Protocol Chair, Duramed Research, Inc
Duramed Research
Not Provided
Principal Investigator: Medical Monitor Duramed Research
Teva Pharmaceutical Industries
August 2012

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