Fibromyalgia Clinical Trial
Official title:
Combining N-of-1 Trials to Assess Fibromyalgia Therapies
Verified date | July 2013 |
Source | Tufts Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6 weeks at a time. The study uses a method that combines results from treatment of individual patients to assess overall treatment effectiveness and help individual patients and their physicians with their treatment decisions. This study will also help compare the results of community-based studies (studies involving private doctors) and studies based at clinical research centers.
Status | Completed |
Enrollment | 58 |
Est. completion date | March 2004 |
Est. primary completion date | March 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients who meet fibromyalgia criteria as defined by the American College of Rheumatology - No systemic illness (current or past) or other contraindications to taking study medications (e.g. known hypersensitivity) - Age 18-60 - Patient willingness, and physician agreement, to discontinue CNS medications/NSAIDs/analgesics for 1 week prior to starting their trial - Patient informed consent and agreement to participate in an N-of-1 trial Exclusion Criteria: - Patients who are currently pregnant or who plan to become pregnant during the study period - Patients with any contraindications to using either amitriptyline or fluoxetine |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Office of Raphael Kieval, MD | Brockton | Massachusetts |
United States | Office of Ronald J. Rapoport, MD | Fall River | Massachusetts |
United States | Office of Eileen Winston, MD | Framingham | Massachusetts |
United States | Office of Nicola Mogavero, MD | Melrose | Massachusetts |
United States | Office of Jacqueline Feuer, MD | Needham | Massachusetts |
United States | Newton-Wellesley Hospital | Newton | Massachusetts |
United States | Office of Sharon A. Stotsky, MD | North Reading | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts Medical Center | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Goldenberg D, Mayskiy M, Mossey C, Ruthazer R, Schmid C. A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia. Arthritis Rheum. 1996 Nov;39(11):1852-9. — View Citation
Guyatt G, Sackett D, Adachi J, Roberts R, Chong J, Rosenbloom D, Keller J. A clinician's guide for conducting randomized trials in individual patients. CMAJ. 1988 Sep 15;139(6):497-503. — View Citation
Guyatt G, Sackett D, Taylor DW, Chong J, Roberts R, Pugsley S. Determining optimal therapy--randomized trials in individual patients. N Engl J Med. 1986 Apr 3;314(14):889-92. — View Citation
Larson EB. N-of-1 clinical trials. A technique for improving medical therapeutics. West J Med. 1990 Jan;152(1):52-6. — View Citation
Zucker DR, Ruthazer R, Schmid CH, Feuer JM, Fischer PA, Kieval RI, Mogavero N, Rapoport RJ, Selker HP, Stotsky SA, Winston E, Goldenberg DL. Lessons learned combining N-of-1 trials to assess fibromyalgia therapies. J Rheumatol. 2006 Oct;33(10):2069-77. — View Citation
Zucker DR, Schmid CH, McIntosh MW, D'Agostino RB, Selker HP, Lau J. Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. J Clin Epidemiol. 1997 Apr;50(4):401-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FIbromyalgia Impact Questionnaire scores | At baseline,each treatment period, and at 3 mo follow up | No |
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