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

Sponsor:	Duramed Research
Information provided by (Responsible Party):	Duramed Research
ClinicalTrials.gov Identifier:	NCT00685113

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 III

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:

MedlinePlus related topics: Urinary Incontinence

U.S. FDA Resources

Further study details as provided by 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) ] [ 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:	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 22, 2011
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 February 12, 2012