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A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxybutynin topical gel
Placebo topical gel
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring OAB, anticholineric, oxybutynin, urge urinary incontinence

Eligibility Criteria

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

Inclusion Criteria: Females and males, 18 years of older with overactive bladder symptoms Exclusion Criteria: Treatable conditions that may cause urinary incontinence Medical conditions in which it would be unsafe to use an anti-cholinergic agent. The use of concomitant drugs that would confound the efficacy evaluation. The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxybutynin topical gel

Placebo topical gel

Arm Description

Oxybutynin topical gel

placebo topical gel

Outcomes

Primary Outcome Measures

Baseline Average Number of Daily Incontinence Episodes
Average number of daily incontinence episodes at baseline
Change From Baseline in Average Daily Number of Incontinence Episodes
Change from Baseline to Week 12 in average daily number of incontinence episodes

Secondary Outcome Measures

Baseline Average Daily Urinary Frequency
Number of daily urinary voids
Change From Baseline in Average Daily Urinary Frequency
Change from baseline in average daily urinary frequency
Baseline Average Urine Void Volume
Baseline average urine void volume
Change From Baseline in Average Urine Void Volume
Change from baseline to Week 12 in average urine void volume

Full Information

First Posted
July 10, 2006
Last Updated
April 13, 2010
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00350636
Brief Title
A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
Official Title
Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
OAB, anticholineric, oxybutynin, urge urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
789 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxybutynin topical gel
Arm Type
Experimental
Arm Description
Oxybutynin topical gel
Arm Title
Placebo topical gel
Arm Type
Placebo Comparator
Arm Description
placebo topical gel
Intervention Type
Drug
Intervention Name(s)
Oxybutynin topical gel
Other Intervention Name(s)
Oxybutynin
Intervention Description
1 application daily to skin for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo topical gel
Other Intervention Name(s)
Placebo
Intervention Description
1 application daily to skin for 12 weeks
Primary Outcome Measure Information:
Title
Baseline Average Number of Daily Incontinence Episodes
Description
Average number of daily incontinence episodes at baseline
Time Frame
Baseline
Title
Change From Baseline in Average Daily Number of Incontinence Episodes
Description
Change from Baseline to Week 12 in average daily number of incontinence episodes
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Baseline Average Daily Urinary Frequency
Description
Number of daily urinary voids
Time Frame
Baseline
Title
Change From Baseline in Average Daily Urinary Frequency
Description
Change from baseline in average daily urinary frequency
Time Frame
Baseline to 12 weeks
Title
Baseline Average Urine Void Volume
Description
Baseline average urine void volume
Time Frame
Baseline
Title
Change From Baseline in Average Urine Void Volume
Description
Change from baseline to Week 12 in average urine void volume
Time Frame
Change from Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females and males, 18 years of older with overactive bladder symptoms Exclusion Criteria: Treatable conditions that may cause urinary incontinence Medical conditions in which it would be unsafe to use an anti-cholinergic agent. The use of concomitant drugs that would confound the efficacy evaluation. The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Caramelli, MS
Organizational Affiliation
Watson Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Homewood
State/Province
Alabama
Country
United States
City
Mobile
State/Province
Alabama
Country
United States
City
Montgomery
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Buena Park
State/Province
California
Country
United States
City
Laguna Woods
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Waterbury
State/Province
Connecticut
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
DeLand
State/Province
Florida
Country
United States
City
Leesburg
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Plantation
State/Province
Florida
Country
United States
City
Tallahassee
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Alpharetta
State/Province
Georgia
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Belville
State/Province
Illinois
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Melrose Park
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
South Bend
State/Province
Indiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Watertown
State/Province
Massachusetts
Country
United States
City
Saginaw
State/Province
Michigan
Country
United States
City
St. Joseph
State/Province
Michigan
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Garden City
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Williamsville
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Lyndhurst
State/Province
Ohio
Country
United States
City
Bethany
State/Province
Oklahoma
Country
United States
City
Edmond
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Newton
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
West Reading
State/Province
Pennsylvania
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19233423
Citation
Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.
Results Reference
result
Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
Description
Drugs@FDA
URL
http://www.gelnique.com/
Description
Watson Pharma product webpage

Learn more about this trial

A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

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