# A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

> **NCT00423813** · PHASE3 · COMPLETED · sponsor: **Jazz Pharmaceuticals** · enrollment: 573 (actual)

## Conditions studied

- Fibromyalgia

## Interventions

- **DRUG:** placebo
- **DRUG:** Xyrem®

## Key facts

- **NCT ID:** NCT00423813
- **Lead sponsor:** Jazz Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-12
- **Primary completion:** 2009-04
- **Final completion:** 2009-06
- **Target enrollment:** 573 (ACTUAL)
- **Last updated:** 2012-01-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00423813

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00423813, "A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT00423813. Licensed CC0.

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