Fibromyalgia of Less Than One Year Duration. Study of Pregabalin
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | September 2011 |
| End Date: | January 2013 |
| Contact: | Dr Don L Goldenberg, MD |
| Email: | dgoldenberg@partners.org |
| Phone: | 617-243-5440 |
Fibromyalgia of Less Than One Year Duration in Primary Care: Treatment Response in a Double Blind, Placebo Controlled Study of Pregabalin
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.
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.
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
II. 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.
At the baseline visit, each subject will be asked if they wish to consider enrolling in Part
II. 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.
Inclusion Criteria:
- • Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix)
- Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix)
- Patients have a pain VAS > 4
- Patients are able to understand and sign informed consent
- Patients are able to understand and complete study questionnaires
- 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).
- Age - > 18
- 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:
- • Patients with a significant musculoskeletal or rheumatic disorder that may confuse
the diagnosis
- Any subject with suicidal thoughts in the past or currently
- Patient with a history of renal disease, heart disease, bleeding problems or low
platelet counts
- Women who are breast feeding
- Men or women who plan to have children during the course of the study
- 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
- Unable to discontinue any mediations used for sleep disturbances
- Patients currently being treated for any psychiatric illness including
depression or anxiety disorder
- Patients currently taking antidepressant, anti-anxiety, or antipsychotic
medications.
- Inability to understand and sign informed consent and complete questionnaires.
We found this trial at
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Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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