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NCT00124306 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)
A Phase 3 study of Interstitial Cystitis and Bladder Diseases, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 271
- Enrollment target
- 10
- Study locations
NCT00124306 is a Phase 3 study of Interstitial Cystitis and Bladder Diseases that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 271 participants, below the 352-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (23% lower). The trial reports 10 study locations across 9 states.
The verdict
NCT00124306, a Phase 3 study of Interstitial Cystitis and Bladder Diseases, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 271 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined by symptoms--frequent urination day and night and increasing pain as the bladder fills--according to the International Continence Society. The syndrome includes interstitial cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women. Estimates for PBS vary widely, but as many as 10 million people may suffer from this condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication used for depression, the way it works makes it useful for treating the pain of fibromyalgia, multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder, helping to relieve the symptoms of pain and frequent urination.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Amitriptyline
Study Locations (10)
Michigan
- Henry Ford Hospital - Detroit
- William Beaumont Hospital - Royal Oak
California
- Stanford University Medical Center - Stanford
Illinois
- Loyola University Medical Center - Maywood
Iowa
- University of Iowa Hospitals and Clinic - Iowa City
Maryland
- University of Maryland - Baltimore
New York
- University of Rochester Medical Center - Rochester
Pennsylvania
- University of Pennsylvania - Philadelphia
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00124306
The ClinicalTrials.gov registry entry for NCT00124306 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 352-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (23% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Interstitial Cystitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00124306 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Michigan, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT00124306 about?
NCT00124306 is a clinical study titled "Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)". This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined by symptoms--frequent urination day and night and increasing pain as the bladder fills--according to the Interna...
What is the current status of trial NCT00124306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 271 participants. The study started on 2005-02. Estimated completion is 2008-12.
What conditions does trial NCT00124306 study?
This clinical trial studies the following conditions: Interstitial Cystitis, Bladder Diseases.
What interventions are being tested in trial NCT00124306?
The interventions under investigation include: Placebo (OTHER), Amitriptyline (DRUG).
Who is sponsoring clinical trial NCT00124306?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00124306 being conducted?
This trial has 10 study locations across California, Illinois, Iowa, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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