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Completed Phase 2 Interventional Results available

Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia

ClinicalTrials.gov ID: NCT00087555

Public ClinicalTrials.gov record NCT00087555. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 6:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00087555
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Jazz Pharmaceuticals
Industry
Enrollment
195 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2004
Primary completion
Mar 31, 2005
Completion
Dec 31, 2005
Last update posted
Jan 23, 2012

2004 – 2006

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
20
Facility City State ZIP Site status
Radiant Research Scottsdale Arizona 85251
Osteoporosis Medical Center Beverly Hills California 90211
Wallace Rheumatic Study Center Los Angeles California 90048
Miami Research Associates Miami Florida 33173
Radiant Research, Inc. West Palm Beach Florida 33407
Central Kentucky Research Associates, Inc. Lexington Kentucky 40509
LSU Health Sciences Center Shreveport Louisiana 71130-3932
Richard N. Podell, MD Springfield New Jersey 07081
Duke University Medical Center Durham North Carolina 27710
Alvin Daughtridge Arthritis Center Lenoir North Carolina 28645
C.A.R.E. Center Raleigh North Carolina 27609
Cleveland Sleep Center Middlebrook Heights Ohio 44130
Lynn Health Science Institute Oklahoma City Oklahoma 73112
Oregon Health and Science University Portland Oregon 97239
Altoona Center for Clinical Research Duncansville Pennsylvania 16635
Abigail Rebecca Neiman, MD Katy Texas 77450
The University of Texas Health Science Center San Antonio Texas 78229
Stress Medicine Clinic -- HealthSouth Rehabilitation Hospital Sandy City Utah 84094
Pacific Rheumatology Research, Inc. Renton Washington 98055
Seattle Rheumatology Associates Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00087555, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 23, 2012 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00087555 live on ClinicalTrials.gov.

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