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NCT00000428 · ClinicalTrials.gov registry record · Phase 4

Combining N-of-1 Trials to Assess Fibromyalgia Treatments

A Phase 4 study, sponsored by Tufts Medical Center.

Completed
Registry status
Phase 4
Development phase
58
Enrollment target

NCT00000428 is a Phase 4 study that has completed, run by Tufts Medical Center. The registered enrollment target is 58 participants.

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The verdict

NCT00000428, a Phase 4 study, has completed, sponsored by Tufts Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
58 participants
Enrollment target

Study 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.

Interventions

  • DRUG Amitriptyline
  • DRUG Amitriptyline plus Fluoxitine

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2000-09
Est. Completion 2004-03
Phase Phase 4

Sponsor

Tufts Medical Center

169 total trials

What the Registry Record Tells You About NCT00000428

The ClinicalTrials.gov registry entry for NCT00000428 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Amitriptyline is the first listed.

NCT00000428 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000428 about?

NCT00000428 is a clinical study titled "Combining N-of-1 Trials to Assess Fibromyalgia Treatments". 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 us...

What is the current status of trial NCT00000428?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2000-09. Estimated completion is 2004-03.

What interventions are being tested in trial NCT00000428?

The interventions under investigation include: Amitriptyline (DRUG), Amitriptyline plus Fluoxitine (DRUG).

Who is sponsoring clinical trial NCT00000428?

This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.