Number of subjects reporting adverse events.
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Brief Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Condition or Disease
- Fibromyalgia
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 560 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Non-Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Dec 01, 2006 | |
|---|---|---|
| Primary Completion: | Jan 01, 2010 | ACTUAL |
| Completion Date: | Jan 01, 2010 | ACTUAL |
| Study First Posted: | Jan 18, 2007 | ESTIMATED |
| Results First Posted: | Oct 20, 2011 | ESTIMATED |
| Last Updated: | Mar 28, 2012 |
Sponsors / Collaborators
Location
The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.
Participant Groups
-
No description provided
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
* Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.
Exclusion Criteria:
* Subject terminated early from either study 06-009 or 06-008.
* Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
* Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
* Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
* Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.
Exclusion Criteria:
* Subject terminated early from either study 06-009 or 06-008.
* Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
* Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
Primary Outcomes
More Details
| NCT Number: | NCT00423605 |
|---|---|
| Other IDs: | 06-010 |
| Study URL: | https://clinicaltrials.gov/study/NCT00423605 |
Last updated: Sep 29, 2023