Completed PHASE2 INTERVENTIONAL 3-arm NCT00087555

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

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

Sponsor: Jazz Pharmaceuticals

Conditions Fibromyalgia

Interventions Placebo Xyrem (sodium oxybate) oral solution

Updated 7 times since 2017 Last updated: Jan 20, 2012 Started: Jul 31, 2004 Primary completion: Apr 30, 2005 Completion: Jan 31, 2006

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Fibromyalgia and is currently completed. Jazz Pharmaceuticals leads this study, which shows 7 recorded versions since 2004 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Jul 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Jazz Pharmaceuticals

Data source: Jazz Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Beverly Hills, United States , Duncansville, United States , Durham, United States , Katy, United States , Lenoir, United States , Lexington, United States , Los Angeles, United States , Miami, United States , Middlebrook Heights, United States , Oklahoma City, United States and 10 more locations