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

Completed · Phase 2 · Has a placebo group

Conditions studied: Urinary Incontinence

In brief

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

Key facts

Study ID

NCT00196404

Run by

Duramed Research

People needed

800

Starts

2004-10-01

Expected to finish

2006-12-01

Last updated by the study team

2012-08-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of overactive bladder and incontinence for at least 6 months
• Using birth control or menopausal
• Willing to discontinue current medication for overactive bladder

You may not qualify if…

• 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

Where it is running

• Duramed Investigational Site — Birmingham, Alabama, United States
• Duramed Investigational Site — Huntsville, Alabama, United States
• Duramed Investigational Site — Mobile, Alabama, United States
• Duramed Research Site — Phoenix, Arizona, United States
• Duramed Research Site — Tucson, Arizona, United States
• Duramed Investigational Site — Little Rock, Arkansas, United States
• Duramed Investigational Site — San Diego, California, United States
• Duremed Research Site — San Diego, California, United States
• Duramed Investigational Site — Aurora, Colorado, United States
• Duramed Research Site — Colorado Springs, Colorado, United States
• Duramed Investigational Site — Denver, Colorado, United States
• Duramed Investigational Site — Waterbury, Connecticut, United States
• Duramed Investigational Site — Aventura, Florida, United States
• Duramed Research Site — Gainesville, Florida, United States
• Duramed Investigational Site — Decatur, Georgia, United States
• Duramed Research Site — Sandy Springs, Georgia, United States
• Duramed Investigational Site — Boise, Idaho, United States
• Duramed Investigational Site — Boise, Indiana, United States
• Duramed Investigational Site — Evansville, Indiana, United States
• Duramed Investigational Site — Fort Wayne, Indiana, United States
• Duramed Investigational Site — Indianapolis, Indiana, United States
• Duramed Investigational Site — Jeffersonville, Indiana, United States
• Duramed Investigational Site — Meridian, Indiana, United States
• Duramed Investigational Site — Shreveport, Louisiana, United States
• Duramed Investigational Site — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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