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

NCT ID: NCT00350636

Last Updated: 2010-05-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

789 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxybutynin topical gel

Oxybutynin topical gel

Group Type EXPERIMENTAL

Oxybutynin topical gel

Intervention Type DRUG

1 application daily to skin for 12 weeks

Placebo topical gel

placebo topical gel

Group Type PLACEBO_COMPARATOR

Placebo topical gel

Intervention Type OTHER

1 application daily to skin for 12 weeks

Interventions

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Oxybutynin topical gel

1 application daily to skin for 12 weeks

Intervention Type DRUG

Placebo topical gel

1 application daily to skin for 12 weeks

Intervention Type OTHER

Other Intervention Names

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Oxybutynin Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Watson

Principal Investigators

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Kim Caramelli, MS

Role: STUDY_DIRECTOR

Watson Pharmaceuticals

Locations

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Birmingham, Alabama, United States

Site Status

Homewood, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Buena Park, California, United States

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Laguna Woods, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Waterbury, Connecticut, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Leesburg, Florida, United States

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Ocala, Florida, United States

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Plantation, Florida, United States

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Tallahassee, Florida, United States

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West Palm Beach, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Belville, Illinois, United States

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Chicago, Illinois, United States

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Melrose Park, Illinois, United States

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Evansville, Indiana, United States

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South Bend, Indiana, United States

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Shreveport, Louisiana, United States

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Watertown, Massachusetts, United States

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Saginaw, Michigan, United States

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Saint Joseph, Michigan, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Garden City, New York, United States

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New York, New York, United States

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Williamsville, New York, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Lyndhurst, Ohio, United States

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Bethany, Oklahoma, United States

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Edmond, Oklahoma, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Newton, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Greer, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19233423 (View on PubMed)

Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Reference Type DERIVED
PMID: 37160401 (View on PubMed)

Related Links

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Other Identifiers

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OG05009

Identifier Type: -

Identifier Source: org_study_id

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