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Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)
NCT00124306 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00124306 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Michigan, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00124306?
The interventions under investigation include: Placebo (OTHER), Amitriptyline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00124306?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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