A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00685113
First received: May 23, 2008
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.


Condition Intervention Phase
Overactive Bladder
Drug: DR-3001
Drug: Placebo
Phase 3

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, Parallel Group Study to Evaluate the Efficacy and Safety of Two Doses of DR-3001 Versus Placebo in Women With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change in total weekly number of incontinence (urge and stress)episodes [ Time Frame: Baseline to end-of-treamtent (Week 12/Early withdrawal) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in average daily urinary frequency and average void volume [ Time Frame: Baseline to end-of-treamtent (Week 12/Early withdrawal) ] [ Designated as safety issue: No ]
  • Proportion of subjects with no incontinence episodes recorded in the final 3-day diary [ Time Frame: Final 3-day diary ] [ Designated as safety issue: No ]
  • 3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question [ Time Frame: Baseline to end-of-treatment (Week 12/Early Withdrawal) ] [ Designated as safety issue: No ]
  • Adverse events (AEs) reported by subjects or identified by the investigator [ Time Frame: Basline to end-of-treatment (Week 12/Early Withdrawal) ] [ Designated as safety issue: Yes ]

Enrollment: 1104
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-3001
4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
Experimental: 2 Drug: DR-3001
6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
Placebo Comparator: 3 Drug: Placebo
Placebo vaginal ring inserted vaginally and replaced every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months
  • Able to distinguish between stress and urge incontinence
  • During the Screening Period able to demonstrate the presence of overactive bladder with urge incontinence based on diary entries
  • Others as dictated by FDA-approved protocol

Exclusion Criteria:

  • Stress incontinence, continuous incontinence or overflow urinary incontinence
  • Chronic illness, neurological dysfunction or injury that could cause incontinence
  • Pregnant, breastfeeding, or gave birth in the last 6 months
  • Others as dictated by FDA-approved protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685113

  Show 84 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Research Protocol Chair Duramed Research, Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00685113     History of Changes
Other Study ID Numbers: DR-OXY-301
Study First Received: May 23, 2008
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014