Fibromyalgia of Less Than One Year Duration. Study of Pregabalin
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate whether pregabalin is effective in treating subjects who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for treatment of fibromyalgia. the purpose of the study is to see if subjects identified through their primary care physicians who have fibromyalgia and have had symptoms for less than one year respond to pregabalin and to identify characteristics of that response.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
The randomized clinical trial of pregabalin in early-onset fibromyalgia.
At the baseline visit, each subject will be asked if they wish to consider enrolling in Part
- If they agree, the details of the study will be explained and Dr Goldenberg will consent those who wish to enroll in Part II. The first 75 patients who consent will be enrolled in the study, the randomized clinical trial of pregabalin in early-onset fibromyalgia.
After a study subject has been enrolled, they will be randomized to one of two treatment groups. All subjects will be randomized, 1:1 either to the pregabalin group (group A) or the placebo group (group B). Randomization will take place after enrollment via selection of one of a multitude of envelopes containing a random number. Each random number will have been preassigned to either Group A or group B.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pregabalin
|
Drug: Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Other Names:
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| Placebo Comparator: Placebo
|
Drug: Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in pain VAS from study entry to end of study [12 weeks]
Secondary Outcome Measures
- Change in total score FIQ from study entry to last visit. [12 weeks]
- Change in total score FM 2010 Clinical Scale from study entry to last visit. [12 Weeks]
- Change in PGIC from study entry to last visit. [12 weeks]
- Change in total score for HRQOL from study entry to last visit. [12 Weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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• Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix)
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Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix)
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Patients have a pain VAS > 4
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Patients are able to understand and sign informed consent
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Patients are able to understand and complete study questionnaires
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Patients are prepared to discontinue all pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), and medications for sleep or mood disturbances two weeks prior to beginning the study. Acetaminophen, up to 2 extra-strength, three times daily, will be allowed for break-through pain. Medication use will be surveyed at each visit (See Appendix).
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Age - > 18
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Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the study period
Exclusion Criteria:
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• Patients with a significant musculoskeletal or rheumatic disorder that may confuse the diagnosis
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Any subject with suicidal thoughts in the past or currently
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Patient with a history of renal disease, heart disease, bleeding problems or low platelet counts
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Women who are breast feeding
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Men or women who plan to have children during the course of the study
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Unable to discontinue any medications prescribed for pain, other than acetaminophen, or any medications for sleep or mood disturbances for at least 2 weeks before the study
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Unable to discontinue any mediations used for sleep disturbances
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Patients currently being treated for any psychiatric illness including depression or anxiety disorder
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Patients currently taking antidepressant, anti-anxiety, or antipsychotic medications.
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Inability to understand and sign informed consent and complete questionnaires.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Newton-Wellesley Hospital | Newton | Massachusetts | United States | 02462 |
Sponsors and Collaborators
- Newton-Wellesley Hospital
- Pfizer
Investigators
- Principal Investigator: Don Goldenberg, MD, Newton-Wellesley Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Clauw DJ, Crofford LJ. Chronic widespread pain and fibromyalgia: what we know, and what we need to know. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):685-701. Review.
- Goldenberg DL. Fibromyalgia syndrome a decade later: what have we learned? Arch Intern Med. 1999 Apr 26;159(8):777-85. Review.
- Goldenberg DL. Introduction: fibromyalgia and its related disorders. J Clin Psychiatry. 2008;69 Suppl 2:4-5.
- Goldenberg DL. Pharmacological treatment of fibromyalgia and other chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):499-511. Review.
- Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72.
- N11-507