# Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

> **NCT00803023** · PHASE3 · COMPLETED · sponsor: **Jazz Pharmaceuticals** · enrollment: 129 (actual)

## Conditions studied

- Fibromyalgia

## Interventions

- **DRUG:** Sodium Oxybate
- **DRUG:** Sodium Oxybate & 6 Tablets
- **DRUG:** Sodium Oxybate & 8 Tablets
- **DRUG:** Sodium Oxybate Oral Solution (6 grams)

## Key facts

- **NCT ID:** NCT00803023
- **Lead sponsor:** Jazz Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-03
- **Primary completion:** 2010-07
- **Final completion:** —
- **Target enrollment:** 129 (ACTUAL)
- **Last updated:** 2011-08-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00803023

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00803023, "Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT00803023. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*