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Completed Phase 4 Interventional

Combining N-of-1 Trials to Assess Fibromyalgia Treatments

ClinicalTrials.gov ID: NCT00000428

Public ClinicalTrials.gov record NCT00000428. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Combining N-of-1 Trials to Assess Fibromyalgia Therapies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00000428
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Tufts Medical Center
Other
Enrollment
58 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2000
Primary completion
Feb 29, 2004
Completion
Feb 29, 2004
Last update posted
Jul 31, 2013

2000 – 2004

United States locations

U.S. sites
7
U.S. states
1
U.S. cities
7
Facility City State ZIP Site status
Office of Raphael Kieval, MD Brockton Massachusetts 02402
Office of Ronald J. Rapoport, MD Fall River Massachusetts 02720
Office of Eileen Winston, MD Framingham Massachusetts 01702
Office of Nicola Mogavero, MD Melrose Massachusetts 02176
Office of Jacqueline Feuer, MD Needham Massachusetts 02192
Newton-Wellesley Hospital Newton Massachusetts 02162
Office of Sharon A. Stotsky, MD North Reading Massachusetts 01864

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000428, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2013 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00000428 live on ClinicalTrials.gov.

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