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Sponsored by: |
Orphan Medical |
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Information provided by: | Orphan Medical |
ClinicalTrials.gov Identifier: | NCT00087555 |
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.
Condition | Intervention | Phase |
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Fibromyalgia |
Drug: Xyrem (sodium oxybate) oral solution Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem(R) (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia |
Enrollment: | 320 |
Study Start Date: | July 2004 |
Study Completion Date: | January 2006 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
Sodium oxybate 6.0 g per day.
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Drug: Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks.
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3: Placebo Comparator
Placebo (one of two doses matching active treatment by volume).
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Drug: Placebo
Placebo one of two doses matching active treatment by volume for 8 weeks.
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1: Experimental
Sodium oxybate 4.5 g per day.
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Drug: Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks.
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Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic that induces and consolidates sleep. In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients. This trial is designed to test this hypothesis. Patients who enroll in this study will stop taking any prescription medications for fibromyalgia (over-the-counter pain relievers will be permitted). They will then take either Xyrem alone or placebo alone. Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment. Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Have any of the following medical conditions:
Have taken any of these therapies:
Unwilling to stop these therapies during course of trial:
Have any of the following clinical laboratory results:
Have any of the following socio-economic factors:
United States, Arizona | |
Radiant Research | |
Scottsdale, Arizona, United States, 85251 | |
United States, California | |
Wallace Rheumatic Study Center | |
Los Angeles, California, United States, 90048 | |
Osteoporosis Medical Center | |
Beverly Hills, California, United States, 90211 | |
United States, Florida | |
Radiant Research, Inc. | |
West Palm Beach, Florida, United States, 33407 | |
Miami Research Associates | |
Miami, Florida, United States, 33173 | |
United States, Kentucky | |
Central Kentucky Research Associates, Inc. | |
Lexington, Kentucky, United States, 40509 | |
United States, Louisiana | |
LSU Health Sciences Center | |
Shreveport, Louisiana, United States, 71130-3932 | |
United States, New Jersey | |
Richard N. Podell, MD | |
Springfield, New Jersey, United States, 07081 | |
United States, North Carolina | |
Alvin Daughtridge Arthritis Center | |
Lenoir, North Carolina, United States, 28645 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
C.A.R.E. Center | |
Raleigh, North Carolina, United States, 27609 | |
United States, Ohio | |
Cleveland Sleep Center | |
Middlebrook Heights, Ohio, United States, 44130 | |
United States, Oklahoma | |
Lynn Health Science Institute | |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Altoona Center for Clinical Research | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Texas | |
The University of Texas Health Science Center | |
San Antonio, Texas, United States, 78229 | |
Abigail Rebecca Neiman, MD | |
Katy, Texas, United States, 77450 | |
United States, Utah | |
Stress Medicine Clinic -- HealthSouth Rehabilitation Hospital | |
Sandy, Utah, United States, 84094 | |
United States, Washington | |
Pacific Rheumatology Research, Inc. | |
Renton, Washington, United States, 98055 | |
Seattle Rheumatology Associates | |
Seattle, Washington, United States, 98104 |
Study Director: | Yanping Zheng, MD | Jazz Pharmaceuticals, Inc |
Responsible Party: | Jazz Pharmaceuticals, Inc. ( Senior Director Clinical Development ) |
Study ID Numbers: | OMC-SXB-26 |
Study First Received: | July 12, 2004 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00087555 |
Health Authority: | United States: Food and Drug Administration |
Fibromyalgia Pain |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases Sodium Oxybate |
Anesthetics, Intravenous Adjuvants, Anesthesia Anesthetics, General Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Central Nervous System Depressants Anesthetics Central Nervous System Agents Pharmacologic Actions |