Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder - Full Text View

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00196404

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Urinary Incontinence

U.S. FDA Resources

Further study details as provided by Duramed Research:

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
1: Experimental	Drug: DR-3001a 4mg daily vaginally
2: Experimental	Drug: DR-3001b 6 mg vaginally daily
3: Placebo Comparator	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 Research, Inc ( Duramed Protocol Chair )
Study ID Numbers:	BR-OXY-202
Study First Received:	September 13, 2005
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00196404 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

overactive bladder
urge incontinence
urinary incontinence

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases

Urination Disorders
Urinary Bladder Diseases
Urinary Incontinence
Urinary Incontinence, Urge

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases

Urination Disorders
Urinary Bladder Diseases
Urinary Incontinence

ClinicalTrials.gov processed this record on September 03, 2009