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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: Completed Phase 4 study, sponsored by Tufts Medical Center.
NCT00000428 is a Phase 4 study that has completed, run by Tufts Medical Center. The registered enrollment target is 58 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2000-09 |
| Est. Completion | 2004-03 |
| Phase | Phase 4 |
What the finished NCT00000428 record still lists
NCT00000428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Amitriptyline is the first listed.
NCT00000428 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000428's enrollment target sits among peer trials
58 1205th of 2000 higher than 792 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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