Combining N-of-1 Trials to Assess Fibromyalgia Treatments
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|ClinicalTrials.gov Identifier: NCT00000428|
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : August 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Amitriptyline Drug: Amitriptyline plus Fluoxitine||Phase 4|
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 fibromyalgia (FM). It will also compare community-based and center-based trial results. We will ask community-based, board-certified rheumatologists to participate as investigators and we will also carry out a center-based study (at Newton-Wellesley Hospital). Physicians will ask patients meeting eligibility criteria to participate in this study and undergo an N-of-1 trial.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Combining N-of-1 Trials to Assess Fibromyalgia Therapies|
|Study Start Date :||September 2000|
|Actual Primary Completion Date :||March 2004|
|Actual Study Completion Date :||March 2004|
Patients received each intervention multiple times in random-order crossover design.
Amitriptyline 25 mg po
Other Name: Elavil
Drug: Amitriptyline plus Fluoxitine
Amitriptyline 25 mg po plus Fluoxitine 20 mg po
Other Name: elavil plus prozac
- FIbromyalgia Impact Questionnaire scores [ Time Frame: At baseline,each treatment period, and at 3 mo follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000428
|United States, Massachusetts|
|Office of Raphael Kieval, MD|
|Brockton, Massachusetts, United States, 02402|
|Office of Ronald J. Rapoport, MD|
|Fall River, Massachusetts, United States, 02720|
|Office of Eileen Winston, MD|
|Framingham, Massachusetts, United States, 01702|
|Office of Nicola Mogavero, MD|
|Melrose, Massachusetts, United States, 02176|
|Office of Jacqueline Feuer, MD|
|Needham, Massachusetts, United States, 02192|
|Newton, Massachusetts, United States, 02162|
|Office of Sharon A. Stotsky, MD|
|North Reading, Massachusetts, United States, 01864|
|Principal Investigator:||Deborah R. Zucker||New England Medical Center, Tufts University School of Medicine|