Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000428
Status:
COMPLETED
Last Update Posted:
2013-08-01
First Post:
2000-01-18
Brief Title:
Combining N-of-1 Trials to Assess Fibromyalgia Treatments
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Combining N-of-1 Trials to Assess Fibromyalgia Therapies
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine AMFL 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
Detailed Description:
This study will use the combined N-of-1 method to compare the effectiveness of the combination therapy amitriptyline and fluoxetine AMFL 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 AMFL 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 patients results classic one-sided t-test and 2 using the patients 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 patients 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
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 AMFL 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 patients results classic one-sided t-test and 2 using the patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-038 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR045416 |
| R01AR045416 | NIH | None | None |