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NCT00673452 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 530
- Enrollment target
NCT00673452: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT00673452 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 530 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00673452, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 530 participants
- Enrollment target
Study Summary
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.
Primary Outcome
The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."
Interventions
- DRUG placebo
- DRUG duloxetine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
What the finished NCT00673452 record still lists
NCT00673452 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00673452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00673452 about?
NCT00673452 is a clinical study titled "A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia". The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive...
What is the current status of trial NCT00673452?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 530 participants. The study started on 2008-06. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00673452?
The interventions under investigation include: placebo (DRUG), duloxetine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00673452?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00673452's enrollment target sits among peer trials
530 157th of 2000 higher than 1,844 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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