Combining N-of-1 Trials to Assess Fibromyalgia Treatments
NCT ID: NCT00000428
Last Updated: 2013-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2000-09-30
2004-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
NCT00464737
Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
NCT00797797
A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
NCT00357825
Duloxetine Versus Placebo for Fibromyalgia
NCT00489073
The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia
NCT07208357
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Each N-of-1 trial will consist of three paired crossover periods (each 6-weeks long) during which the patient will receive either AM + placebo (placebo every morning and AM 25 mg at night) or combination treatment AM+FL (FL 20 mg in the morning and AM 25 mg at night). The dispensing pharmacy will carry out paired randomization.
We will assess patient evaluations and outcome measures at baseline prior to trial, at the end of each treatment period, and 3 months after completion of the N-of-1 trial. In addition, at baseline, we will obtain demographic information, an electrocardiogram, and baseline blood tests. We may ask patients to have additional blood tests at the period evaluations. We will also do a pregnancy test for all women of child-bearing age enrolling in the study. The main study outcome measure will be the Fibromyalgia Impact Questionnaire (FIQ). Additional measures will include the Visual Analog Scales (VAS) for pain, sleep, global well-being; Physician VAS for global well-being; and tender-point score.
We will analyze the results of the N-of-1 trials in two ways: (1) using only the individual patient's results (classic one-sided t-test) and (2) using the patient's results in combination with the results of other patients who underwent similar trials (the combined N-of-1 approach). To obtain the latter information, we will include each patient's results for the collective analysis. We will provide these results back to the physicians and will record the final treatment decisions the physicians reach with their patients. In addition, we will ask both physicians and patients to comment on their participation in an N-of-1 trial and this research process. Followup of patients 3 months after completion of their N-of-1 trial will include determining current medication and a current outcome assessment. Investigators will record all adverse drug reactions and patients withdrawn from studies. They will also record the reason for withdrawal for all patients choosing to withdraw. We will include results from patients who drop out due to reasons other than drug reactions in the combined N-of-1 analyses if completed period pair results are available. An independent safety officer will review all withdrawals.
Results of individual patient trials will be confidential; however, we will combine these results (after removal of patient identifiers) with the results of other patients, and will publish the overall results of this study. We will maintain the connection of results to patient identifiers only to enable us to provide results to individual investigators and their patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Patients received each intervention multiple times in random-order crossover design.
Amitriptyline
Amitriptyline 25 mg po
Amitriptyline plus Fluoxitine
Amitriptyline 25 mg po plus Fluoxitine 20 mg po
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amitriptyline
Amitriptyline 25 mg po
Amitriptyline plus Fluoxitine
Amitriptyline 25 mg po plus Fluoxitine 20 mg po
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 with any contraindications to using either amitriptyline or fluoxetine
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Tufts Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tufts-New England Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Deborah R. Zucker
Role: PRINCIPAL_INVESTIGATOR
New England Medical Center, Tufts University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1002/art.1780391111.
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. doi: 10.1016/s0895-4356(96)00429-5.
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. doi: 10.1056/NEJM198604033141406.
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.
Larson EB. N-of-1 clinical trials. A technique for improving medical therapeutics. West J Med. 1990 Jan;152(1):52-6.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.