FibromyalgiaPhase 3COMBAT-FMNCT01598753
Combined Behavioral and Analgesic Trial for Fibromyalgia
A Phase 3 study testing Tramadol, Cognitive Behavior Therapy for FM and Health Education in people with Fibromyalgia, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Tramadol, Cognitive Behavior Therapy for FM and Health Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to 31 Jul 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females 21-70
- Diagnosis of Fibromyalgia
- Current primary care physician
- Fluent in English
Who cannot join
- Rheumatologic disorders
- Drug and alcohol abuse in the past year
- Psychiatric hospitalization in the past 6 months
- Current use of Tramadol
- Certain antidepressant and other pain medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Rochester
Rochester, New York
University of Washington
Seattle, Washington, 98195
About this study
Official title: Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavioral Therapy Versus Health Education) for Patients With 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 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.
Read more
There are 4 possible study treatment combinations:
- Tramadol + CBT,
- Tramadol + HE,
- Placebo + CBT,
- 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.
- Conditions
- Fibromyalgia
- Being tested
- Tramadol, Placebo, Cognitive Behavior Therapy for FM, Health Education
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day.
Minimum accepted dose of 200mg per day
PlaceboDrug
Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
Cognitive Behavior Therapy for FMBehavioural
Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.
Health EducationBehavioural
Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Active comparator | Not described Receives: Drug: Tramadol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Cognitive Behavior Therapy for FM | Active comparator | Not described Receives: Behavioral: Cognitive Behavior Therapy for FM |
| Health Education | Sham comparator | Not described Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function
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."
Measured: Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Turk, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598753
- Sponsor's protocol ID
- STUDY00001259
- Acronym
- COMBAT-FM
- Status last verified
- Jun 2019
- First submitted
- 1 May 2012
- Last updated
- 26 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavioral Therapy Versus Health Education) for Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01598753
- Acronym / sponsor ID
- COMBAT-FM / STUDY00001259
- Conditions
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 26 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Tramadol + CBT,
- Tramadol + HE,
- Placebo + CBT,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Active comparator | Drug: Tramadol |
| Placebo | Placebo comparator | Drug: Placebo |
| Cognitive Behavior Therapy for FM | Active comparator | Behavioral: Cognitive Behavior Therapy for FM |
| Health Education | Sham comparator | Behavioral: Health Education |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and Females 21-70
- Diagnosis of Fibromyalgia
- Current primary care physician
- Fluent in English
Key exclusion criteria (5 listed)
- Rheumatologic disorders
- Drug and alcohol abuse in the past year
- Psychiatric hospitalization in the past 6 months
- Current use of Tramadol
- Certain antidepressant and other pain medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day. Minimum accepted dose of 200mg per day | Drug | Tramadol |
| PlaceboPharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg | Drug | Placebo |
| Cognitive Behavior Therapy for FMSubjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients. | Behavioural | Cognitive Behavior Therapy for FM |
| Health EducationSubjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia | Behavioural | Health Education |
Primary outcome
Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function
Time frame: Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).
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."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol, Cognitive Behavior Therapy for FM and Health Education in people with Fibromyalgia, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function (time frame: Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.