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NCT00423813 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 573
- Enrollment target
NCT00423813: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT00423813 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 573 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423813, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 573 participants
- Enrollment target
Study Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
Primary Outcome
Percentage of pain VAS responders. Subjects with a \>= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline
Interventions
- DRUG placebo
- DRUG Xyrem®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 573 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00423813 record still lists
NCT00423813 is an interventional study that assigns participants to a tested intervention. The registered 573 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00423813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00423813 about?
NCT00423813 is a clinical study titled "A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.". The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
What is the current status of trial NCT00423813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 573 participants. The study started on 2006-12. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00423813?
The interventions under investigation include: placebo (DRUG), Xyrem® (DRUG).
Who is sponsoring clinical trial NCT00423813?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00423813's enrollment target sits among peer trials
573 663rd of 2000 higher than 1,338 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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