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OpenTrials
Completed

NCT Number: NCT00423605

Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

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Key information

Conditions

Fibromyalgia Arthralgia Joint Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rhumatologie, Amiens, France

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About this study

The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
  • Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.

Exclusion criteria

  • Subject terminated early from either study 06-009 or 06-008.
  • Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
  • Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.

Treatment and study plan

Xyrem®

Drug

flexible dosing

Primary outcomes

  1. Number of Subjects Reporting Adverse Events

    Time frame: Treatment Period (38 weeks)

    Number of subjects reporting adverse events.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study title

A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 18, 2007
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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