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NCT00005575 · ClinicalTrials.gov registry record · Phase 3
Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
NCT00005575 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The verdict
NCT00005575, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study Summary
Approximately 75,000-150,000 patients each year in the United States undergo intensive cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings. These patients often have high levels of disability and suffering and account for $250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term reductions in pain intensity. However, no studies have compared the effects of these two treatments on measures of pain, suffering, and disability at post-treatment and over a one-year follow-up period. Our investigation is a 16-week, randomized controlled outcome study of these interventions and their respective placebo control procedures. One hundred and sixty patients are being recruited for this study. We will assess the effects of our interventions on patients' pain levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our treatment effects as well as their statistical significance.
Interventions
- DRUG Imipramine
- BEHAVIORAL Cognitive-behavior therapy
Trial Details
| Field | Value |
|---|---|
| Start Date | 1999-01 |
| Est. Completion | 2002-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005575
The ClinicalTrials.gov registry entry for NCT00005575 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. 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 0 conditions, and to 2 interventions - of which Imipramine is the first listed.
NCT00005575 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005575 about?
NCT00005575 is a clinical study titled "Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy". Approximately 75,000-150,000 patients each year in the United States undergo intensive cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings. These patients often have high levels of disability and suffering and account for $250,000,000-$500,000,000 in estimate...
What is the current status of trial NCT00005575?
This trial is currently completed. It is a Phase 3 study. The study started on 1999-01. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00005575?
The interventions under investigation include: Imipramine (DRUG), Cognitive-behavior therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00005575?
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.
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