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

Primary Purpose

Urinary Incontinence

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

DR-3001a

DR-3001b

Placebo

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring overactive bladder, urge incontinence, urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change in the total weekly number of incontinence episodes

Secondary Outcome Measures

Average daily urinary frequency

Proportion of patients with no incontinence episodes

Average void volume

Average severity of urgency

Full Information

NCT ID

NCT00196404

First Posted

September 13, 2005

Last Updated

August 17, 2012

Sponsor

Duramed Research

1. Study Identification

Unique Protocol Identification Number

NCT00196404

Brief Title

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

Official Title

A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Duramed Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

Keywords

overactive bladder, urge incontinence, urinary incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

DR-3001a

Intervention Description

4mg daily vaginally

Intervention Type

Drug

Intervention Name(s)

DR-3001b

Intervention Description

6 mg vaginally daily

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Administered vaginally to match experimental arms

Primary Outcome Measure Information:

Title

Change in the total weekly number of incontinence episodes

Time Frame