A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Xyrem®; Drug: placebo

• Registration Number: NCT00423813
• Lead Sponsor: Jazz Pharmaceuticals

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.

Detailed Description

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-two (22) 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 a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-17
• Study First Posted: 2007-01-18
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Results First Submitted: 2011-09-08
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-05
• Results First Posted: 2012-01-10
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 573

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Xyrem®	-
1	placebo	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (115)

East Alabama Arthritis Center; 🇺🇸 Auburn, Alabama, United States

Capstone Clinical Trials, Inc.; 🇺🇸 Birmingham, Alabama, United States

Drug Research and Analysis Corporation; 🇺🇸 Montgomery, Alabama, United States

dba 21st Century Neurology; 🇺🇸 Phoenix, Arizona, United States

Orange County Clinical Trials; 🇺🇸 Anaheim, California, United States

Providence Clinical Research; 🇺🇸 Burbank, California, United States

Med Investigations, Inc.; 🇺🇸 Fair Oaks, California, United States

North Orange County Research Institute, Inc.; 🇺🇸 Fullerton, California, United States

Nerve Pro Research; 🇺🇸 Irvine, California, United States

Northridge Neurological Center; 🇺🇸 Northridge, California, United States

Scroll for more (105 remaining)