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

Watson Pharmaceuticals789 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

789

Conditions

Overactive Bladder

Interventions

Oxybutynin topical gelDRUG

1 application daily to skin for 12 weeks

Placebo topical gelOTHER

1 application daily to skin for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (63)

Outcomes

Primary Outcomes

Baseline Average Number of Daily Incontinence Episodes

Average number of daily incontinence episodes at baseline

Time frame: Baseline

Change From Baseline in Average Daily Number of Incontinence Episodes

Change from Baseline to Week 12 in average daily number of incontinence episodes

Time frame: Baseline to Week 12

Secondary Outcomes

Baseline Average Daily Urinary Frequency

Number of daily urinary voids

Time frame: Baseline

Change From Baseline in Average Daily Urinary Frequency

Change from baseline in average daily urinary frequency

Time frame: Baseline to 12 weeks

Baseline Average Urine Void Volume

Baseline average urine void volume

Time frame: Baseline

Change From Baseline in Average Urine Void Volume

Change from baseline to Week 12 in average urine void volume

Time frame: Change from Baseline to Week 12

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

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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

...and 53 more locations