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.
A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Brief Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
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: | 548 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Aug 01, 2006 | |
|---|---|---|
| Primary Completion: | Sep 01, 2008 | ACTUAL |
| Completion Date: | Dec 01, 2008 | ACTUAL |
| Study First Posted: | Sep 01, 2006 | ESTIMATED |
| Results First Posted: | Nov 30, 2011 | ESTIMATED |
| Last Updated: | Dec 21, 2011 |
Sponsors / Collaborators
Location
The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined, followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.
Participant Groups
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No description provided
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No description provided
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
Exclusion Criteria:
* Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
* Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.
* Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
Exclusion Criteria:
* Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
* Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.
Primary Outcomes
More Details
| NCT Number: | NCT00371137 |
|---|---|
| Other IDs: | 06-008 |
| Study URL: | https://clinicaltrials.gov/study/NCT00371137 |
Last updated: Sep 29, 2023