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

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research ) Identifier:
First received: May 23, 2008
Last updated: July 18, 2016
Last verified: July 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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) ]

Secondary Outcome Measures:
  • Change in average daily urinary frequency and average void volume [ Time Frame: Baseline to end-of-treamtent (Week 12/Early withdrawal) ]
  • Proportion of subjects with no incontinence episodes recorded in the final 3-day diary [ Time Frame: Final 3-day diary ]
  • 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) ]
  • Adverse events (AEs) reported by subjects or identified by the investigator [ Time Frame: Basline to end-of-treatment (Week 12/Early Withdrawal) ]

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
Other Name: Oxybutinyn Vaginal Ring
Experimental: 2 Drug: DR-3001
6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
Other Name: Oxybutinyn Vaginal Ring
Placebo Comparator: 3 Drug: Placebo
Placebo vaginal ring inserted vaginally and replaced every 4 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00685113

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

Responsible Party: Duramed Research Identifier: NCT00685113     History of Changes
Other Study ID Numbers: DR-OXY-301
Study First Received: May 23, 2008
Last Updated: July 18, 2016

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms processed this record on May 22, 2017