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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:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00196404
First received: September 13, 2005
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Urinary Incontinence
 Drug: DR-3001a
Drug: DR-3001b
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change in the total weekly number of incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 800
Study Start Date: October 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-3001a
4mg daily vaginally
Experimental: 2 Drug: DR-3001b
6 mg vaginally daily
Placebo Comparator: 3 Other: Placebo
Administered vaginally to match experimental arms

Detailed Description:

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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196404

  Show 48 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Principal Investigator: Medical Monitor Duramed Research
  More Information

Additional Information:
MedLine Plus - Urinary Incontinence  This link exits the ClinicalTrials.gov site
NIDDK - Bladder Control for Women  This link exits the ClinicalTrials.gov site
NIDDK - Treatment of Bladder Control in Women  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc
ClinicalTrials.gov Identifier: NCT00196404     History of Changes
Other Study ID Numbers: BR-OXY-202
Study First Received: September 13, 2005
Last Updated: August 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
overactive bladder
urge incontinence
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
 Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on October 16, 2012