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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196404
First Posted: September 20, 2005
Last Update Posted: August 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceutical Industries
September 13, 2005
September 20, 2005
August 20, 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 ]
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 ]
  • Proportion of patients with no incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ]
  • Average void volume [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ]
  • Average severity of urgency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ]
  • 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00196404
BR-OXY-202
No
Not Provided
Not Provided
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