Status:
COMPLETED
Combining N-of-1 Trials to Assess Fibromyalgia Treatments
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
This study will use the combined N-of-1 method to compare the effectiveness of the combination therapy amitriptyline and fluoxetine (AM+FL) versus amitriptyline (AM) alone in patients with fibromyalgi...
Eligibility Criteria
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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00000428
Start Date
September 1 2000
End Date
March 1 2004
Last Update
August 1 2013
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Office of Raphael Kieval, MD
Brockton, Massachusetts, United States, 02402
2
Office of Ronald J. Rapoport, MD
Fall River, Massachusetts, United States, 02720
3
Office of Eileen Winston, MD
Framingham, Massachusetts, United States, 01702
4
Office of Nicola Mogavero, MD
Melrose, Massachusetts, United States, 02176