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NCT01598753 · ClinicalTrials.gov registry record · Phase 3
Combined Behavioral and Analgesic Trial for Fibromyalgia
A Phase 3 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 3
- Development phase
- 134
- Enrollment target
NCT01598753 is a Phase 3 study that has completed, run by University of Washington. The registered enrollment target is 134 participants.
The verdict
NCT01598753, a Phase 3 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 134 participants
- Enrollment target
Study Summary
This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls. Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive an inactive pill, called a placebo. There will also be 2 different types of behavioral health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have been recommended for the treatment of patients with FM by the American Pain Society. There are 4 possible study treatment combinations: 1. Tramadol + CBT, 2. Tramadol + HE, 3. Placebo + CBT, 4. Placebo + HE. Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there have been no studies that have evaluated the combination of medication and a behavioral health treatment. The primary purpose of this study is to compare the benefits of the 4 combinations listed.
Interventions
- DRUG Placebo
- BEHAVIORAL Health Education
- DRUG Tramadol
- BEHAVIORAL Cognitive Behavior Therapy for FM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2012-05 |
| Est. Completion | 2018-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01598753
The ClinicalTrials.gov registry entry for NCT01598753 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01598753 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01598753 about?
NCT01598753 is a clinical study titled "Combined Behavioral and Analgesic Trial for Fibromyalgia". This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls. Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others wi...
What is the current status of trial NCT01598753?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2012-05. Estimated completion is 2018-07-31.
What interventions are being tested in trial NCT01598753?
The interventions under investigation include: Placebo (DRUG), Health Education (BEHAVIORAL), Tramadol (DRUG), Cognitive Behavior Therapy for FM (BEHAVIORAL).
Who is sponsoring clinical trial NCT01598753?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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