Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00087555 · ClinicalTrials.gov registry record · Phase 2
Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
NCT00087555: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT00087555 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 195 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00087555, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.
Primary Outcome
The percentage of participants who met all 3 of the following criteria: Reduction of \>=20% from baseline to week 8 in both PVAS \& FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that
Interventions
- DRUG Placebo
- DRUG Xyrem (sodium oxybate) oral solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2004-07 |
| Est. Completion | 2006-01 |
| Phase | Phase 2 |
What the finished NCT00087555 record still lists
NCT00087555 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00087555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00087555 about?
NCT00087555 is a clinical study titled "Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia". The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.
What is the current status of trial NCT00087555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2004-07. Estimated completion is 2006-01.
What interventions are being tested in trial NCT00087555?
The interventions under investigation include: Placebo (DRUG), Xyrem (sodium oxybate) oral solution (DRUG).
Who is sponsoring clinical trial NCT00087555?
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 NCT00087555's enrollment target sits among peer trials
195 350th of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04276922 · 195 participants · NA
Creative Arts Program to Reduce Burnout in Healthcare Professionals
- NCT04829357 · 195 participants
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
- NCT05054738 · 195 participants · NA
CRP and S&A for Inpatient Veterans
- NCT05561595 · 195 participants · NA
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia