Trial · NCT00423813
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
NCT00423813, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2012-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia. Trials, record NCT00423813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00423813
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
- NCT number
- NCT00423813
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 573 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Fibromyalgia
- Interventions
- placebo, Xyrem®
- First posted
- 2007-01-18
- Last updated
- 2012-01-24
- Results first posted
- 2012-01-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Baseline to Week 14 | 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 visit. Endpoint is the average value recorded for the measure during the week prior to week 14. |
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 | Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Baseline to Week 14 | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Placebo | Responder | 20.2 | Percentage of Participants | |
| Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Xyrem (Sodium Oxybate) 4.5g | Responder | 35.4 | Percentage of Participants | |
| Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Xyrem (Sodium Oxybate) 6.0g | Responder | 35.3 | Percentage of Participants | |
| Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Placebo | Non - Responder | 79.8 | Percentage of Participants | |
| Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Xyrem (Sodium Oxybate) 4.5g | Non - Responder | 64.6 | Percentage of Participants | |
| Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Xyrem (Sodium Oxybate) 6.0g | Non - Responder | 64.7 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 188 | |
| Overall Study | STARTED | Xyrem (Sodium Oxybate) 4.5g | 195 | |
| Overall Study | STARTED | Xyrem (Sodium Oxybate) 6.0g | 190 | |
| Overall Study | Treated | Placebo | 188 | |
| Overall Study | Treated | Xyrem (Sodium Oxybate) 4.5g | 194 | |
| Overall Study | Treated | Xyrem (Sodium Oxybate) 6.0g | 189 | |
| Overall Study | COMPLETED | Placebo | 131 | |
| Overall Study | COMPLETED | Xyrem (Sodium Oxybate) 4.5g | 129 | |
| Overall Study | COMPLETED | Xyrem (Sodium Oxybate) 6.0g | 116 | |
| Overall Study | NOT COMPLETED | Placebo | 57 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events177
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 | Palpatations | Cardiac disorders | Placebo | 2 | 188 | |
| other | Palpatations | Cardiac disorders | Xyrem (Sodium Oxybate) 4.5g | 2 | 194 | |
| other | Palpatations | Cardiac disorders | Xyrem (Sodium Oxybate) 6.0g | 4 | 189 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 4 | 188 | |
| other | Vertigo | Ear and labyrinth disorders | Xyrem (Sodium Oxybate) 4.5g | 8 | 194 | |
| other | Vertigo | Ear and labyrinth disorders | Xyrem (Sodium Oxybate) 6.0g | 7 | 189 | |
| other | Vision Blurred | Eye disorders | Placebo | 2 | 188 | |
| other | Vision Blurred | Eye disorders | Xyrem (Sodium Oxybate) 4.5g | 4 | 194 | |
| other | Vision Blurred | Eye disorders | Xyrem (Sodium Oxybate) 6.0g | 3 | 189 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 16 | 188 |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Xyrem (Sodium Oxybate) 4.5g | ||
| Total, all-cause mortality | Xyrem (Sodium Oxybate) 6.0g | ||
| Total, other adverse events | Placebo | 126 | 188 |
| Total, other adverse events | Xyrem (Sodium Oxybate) 4.5g | 146 | 194 |
| Total, other adverse events | Xyrem (Sodium Oxybate) 6.0g | 156 | 189 |
| Total, serious adverse events | Placebo | 3 | 188 |
| Total, serious adverse events | Xyrem (Sodium Oxybate) 4.5g | 2 | 194 |
| Total, serious adverse events | Xyrem (Sodium Oxybate) 6.0g | 3 | 189 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00423813
GET https://conductscience.org/api/trials/v1/NCT00423813/events?page=2