Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
This study has been completed.
Sponsor:
Duramed Research
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00196404
First received: September 13, 2005
Last updated: August 17, 2012
Last verified: August 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence |
Drug: DR-3001a Drug: DR-3001b Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder |
Resource links provided by NLM:
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Change in the total weekly number of incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average daily urinary frequency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
- Proportion of patients with no incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
- Average void volume [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
- Average severity of urgency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 800 |
| Study Start Date: | October 2004 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: DR-3001a
4mg daily vaginally
|
| Experimental: 2 |
Drug: DR-3001b
6 mg vaginally daily
|
| Placebo Comparator: 3 |
Other: Placebo
Administered vaginally to match experimental arms
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196404
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Hide Study LocationsLocations
| United States, Alabama | |
| Duramed Investigational Site | |
| Birmingham, Alabama, United States, 35209 | |
| Duramed Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| Duramed Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Duramed Research Site | |
| Phoenix, Arizona, United States, 85015 | |
| Duramed Research Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Duramed Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Duramed Investigational Site | |
| San Diego, California, United States, 92108 | |
| Duremed Research Site | |
| San Diego, California, United States, 92108 | |
| United States, Colorado | |
| Duramed Investigational Site | |
| Aurora, Colorado, United States, 80012 | |
| Duramed Research Site | |
| Colorado Springs, Colorado, United States, 80909 | |
| Duramed Investigational Site | |
| Denver, Colorado, United States, 80220 | |
| United States, Connecticut | |
| Duramed Investigational Site | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Duramed Investigational Site | |
| Aventura, Florida, United States, 33180 | |
| Duramed Research Site | |
| Gainesville, Florida, United States, 32607 | |
| United States, Georgia | |
| Duramed Investigational Site | |
| Decatur, Georgia, United States, 30034 | |
| Duramed Research Site | |
| Sandy Springs, Georgia, United States, 30328 | |
| United States, Idaho | |
| Duramed Investigational Site | |
| Boise, Idaho, United States, 83712 | |
| United States, Indiana | |
| Duramed Investigational Site | |
| Boise, Indiana, United States, 83705 | |
| Duramed Investigational Site | |
| Evansville, Indiana, United States, 47714 | |
| Duramed Investigational Site | |
| Fort Wayne, Indiana, United States, 46825 | |
| Duramed Investigational Site | |
| Indianapolis, Indiana, United States, 46202 | |
| Duramed Investigational Site | |
| Jeffersonville, Indiana, United States, 47130 | |
| Duramed Investigational Site | |
| Meridian, Indiana, United States, 83642 | |
| United States, Louisiana | |
| Duramed Investigational Site | |
| Shreveport, Louisiana, United States, 71106 | |
| United States, Mississippi | |
| Duramed Investigational Site | |
| Jackson, Mississippi, United States, 39202 | |
| United States, New Hampshire | |
| Duramed Investigational Site | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Duramed Investigational Site | |
| Edison, New Jersey, United States, 08837 | |
| Duramed Investigational Site | |
| Livingston, New Jersey, United States, 07039 | |
| Duramed Investigational Site | |
| Moorestown, New Jersey, United States, 08057 | |
| United States, New York | |
| Duramed Investigational Site | |
| Williamsville, New York, United States, 14221 | |
| United States, Oregon | |
| Duramed Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Duramed Investigational Site | |
| Lancaster, Pennsylvania, United States, 17604 | |
| Duramed Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19114 | |
| United States, Rhode Island | |
| Duramed Investigational Site | |
| Providence, Rhode Island, United States, 02904 | |
| United States, South Carolina | |
| Duramed Investigational Site | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Duramed Investigational Site | |
| Jackson, Tennessee, United States, 38305 | |
| Duramed Investigational Site | |
| Memphis, Tennessee, United States, 38120 | |
| Duramed Investigational Site | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Duramed Investigational Site | |
| Dallas, Texas, United States, 75234 | |
| Duramed Research Site | |
| Houston, Texas, United States, 77024 | |
| Duramed Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Duramed Research Site | |
| Waco, Texas, United States, 76712 | |
| United States, Utah | |
| Duramed Investigational Site | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Washington | |
| Duramed Investigational Site | |
| Seattle, Washington, United States, 98105 | |
| Duramed Research Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Duramed Investigational Site | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Canada, British Columbia | |
| Duramed Investigational Site | |
| Vancouver, British Columbia, Canada, V6T2B5 | |
| Canada, Ontario | |
| Duramed Investigational Site | |
| Toronto, Ontario, Canada, M4N3M5 | |
Sponsors and Collaborators
Duramed Research
Investigators
| Principal Investigator: | Medical Monitor | Duramed Research |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duramed Protocol Chair, Duramed Research, Inc |
| ClinicalTrials.gov Identifier: | NCT00196404 History of Changes |
| Other Study ID Numbers: | BR-OXY-202 |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Teva Pharmaceutical Industries:
|
overactive bladder urge incontinence urinary incontinence |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Bladder, Overactive Urination Disorders Urologic Diseases |
Urological Manifestations Signs and Symptoms Urinary Bladder Diseases |
ClinicalTrials.gov processed this record on May 22, 2013