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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: Completed Phase 3 study, sponsored by University of Washington.
NCT01598753 is a Phase 3 study that has completed, run by University of Washington. The registered enrollment target is 134 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is a reduction of at least 30% on the pain score (mean for 5-day daily pain diary) or improvement of 20% physical function (FIQR) from baseline (pre-treatment) to post-treatment. Individuals who achieve such decrease in pain or increase in function are labeled "responders."
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 |
What the finished NCT01598753 record still lists
NCT01598753 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01598753 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01598753's enrollment target sits among peer trials
134 1585th of 2000 higher than 413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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