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NCT00423605 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 560
- Enrollment target
NCT00423605: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT00423605 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 560 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423605, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 560 participants
- Enrollment target
Study Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Primary Outcome
Number of subjects reporting adverse events.
Interventions
- DRUG Xyrem®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00423605 record still lists
NCT00423605 is an interventional study that assigns participants to a tested intervention. The registered 560 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 (27% lower).
The record links to 0 conditions, and to 1 intervention - of which Xyrem® is the first listed.
NCT00423605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00423605 about?
NCT00423605 is a clinical study titled "Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.". The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
What is the current status of trial NCT00423605?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 560 participants. The study started on 2006-12. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00423605?
The interventions under investigation include: Xyrem® (DRUG).
Who is sponsoring clinical trial NCT00423605?
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 NCT00423605's enrollment target sits among peer trials
560 671st of 2000 higher than 1,328 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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