At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 58 enrolled

Drug / intervention

Amitriptyline +1 moredrug

Likely dose

Amitriptyline 25 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000428

NCT00000428Phase 4Completed

Compare CT.gov

Combining N-of-1 Trials to Assess Fibromyalgia Therapies

Tufts Medical Center·interventional·Posted Jan 19, 2000·Updated Aug 1, 2013

In Brief

A Phase 4 clinical trial evaluating Amitriptyline and Amitriptyline plus Fluoxitine for Fibromyalgia. Completed, enrolled 58 participants across 7 sites.

Detailed 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 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsFibromyalgia

CountriesUnited States

CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

Phase 4CompletedFinished

2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedJan 2000

Enrollment StartSep 2000

Primary CompletionMar 2004

TodayJul 2026

First PostedJan 19, 2000

Enrollment StartSep 1, 2000

Primary CompletionMar 1, 2004

TodayJul 2, 2026

Enrollment to primary: 3.5 yearsPosted 26.5 years ago

Interventions

Amitriptylinedrug

Amitriptyline 25 mg po

Amitriptyline plus Fluoxitinedrug

Amitriptyline 25 mg po plus Fluoxitine 20 mg po