A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

Phase 3

Completed

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

• Registration Number: NCT00371137
• 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-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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-31
• Study First Posted: 2006-09-01
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Results First Submitted: 2011-09-08
• Results First Submitted QC: 2011-10-24
• Results First Posted: 2011-11-30
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 548

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
1	Placebo	-
2	Xyrem®	-

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 (69)

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States

Rheumatology Associates of N. AL, PC; 🇺🇸 Huntsville, Alabama, United States

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

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

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

Northern California Research; 🇺🇸 Carmichael, California, United States

Pasadena Rehabilitation Institute; 🇺🇸 Pasadena, California, United States

Arroyo Medical Group; 🇺🇸 Pismo Beach, California, United States

Sacramento Research Medical Group; 🇺🇸 Sacramento, California, United States

Scroll for more (59 remaining)