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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685113
First Posted: May 28, 2008
Last Update Posted: July 20, 2016
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 (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
  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
Intervention Model: Parallel Assignment
Masking: Double (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 ( Duramed Research ):

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685113


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

Responsible Party: Duramed Research
ClinicalTrials.gov Identifier: NCT00685113     History of Changes
Other Study ID Numbers: DR-OXY-301
First Submitted: May 23, 2008
First Posted: May 28, 2008
Last Update Posted: July 20, 2016
Last Verified: July 2016

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