Trial · NCT00423605
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
NCT00423605, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2011-10-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia. Trials, record NCT00423605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00423605
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
- NCT number
- NCT00423605
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 560 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Fibromyalgia
- Interventions
- Xyrem®
- First posted
- 2007-01-18
- Last updated
- 2012-03-30
- Results first posted
- 2011-10-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Adverse Events | Treatment Period (38 weeks) | Number of subjects reporting adverse events. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reporting Adverse Events | Treatment Period (38 weeks) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reporting Adverse Events | Xyrem 4.5 g to 9.0 g | 498 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Xyrem 4.5 g to 9.0 g | 560 | |
| Overall Study | COMPLETED | Xyrem 4.5 g to 9.0 g | 319 | |
| Overall Study | NOT COMPLETED | Xyrem 4.5 g to 9.0 g | 241 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Xyrem 4.5 g to 9.0 g | 12 | 560 | |
| other | Vision Blurred | Eye disorders | Xyrem 4.5 g to 9.0 g | 18 | 560 | |
| other | Nausea | Gastrointestinal disorders | Xyrem 4.5 g to 9.0 g | 112 | 560 | |
| other | Vomiting | Gastrointestinal disorders | Xyrem 4.5 g to 9.0 g | 52 | 560 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Xyrem 4.5 g to 9.0 g | 15 | 560 | |
| other | Fatigue | General disorders | Xyrem 4.5 g to 9.0 g | 24 | 560 | |
| other | Pyrexia | General disorders | Xyrem 4.5 g to 9.0 g | 14 | 560 | |
| other | Diarrhoea | Gastrointestinal disorders | Xyrem 4.5 g to 9.0 g | 49 | 560 | |
| other | Oedema Peripheral | General disorders | Xyrem 4.5 g to 9.0 g | 13 | 560 | |
| other | Pain | General disorders | Xyrem 4.5 g to 9.0 g | 12 | 560 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Xyrem 4.5 g to 9.0 g | ||
| Total, other adverse events | Xyrem 4.5 g to 9.0 g | 498 | 560 |
| Total, serious adverse events | Xyrem 4.5 g to 9.0 g | 19 | 560 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24286114 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00423605
GET https://conductscience.org/api/trials/v1/NCT00423605/events?page=2