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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Sodium Oxybate	4.5 grams per night taken in two equally divided doses
DRUG	Sodium Oxybate & 6 Tablets	4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
DRUG	Sodium Oxybate & 8 Tablets	6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
DRUG	Sodium Oxybate Oral Solution (6 grams)	6 grams per night taken in two equally divided doses

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-07-01
• First posted: 2008-12-05
• Last updated: 2011-08-19
• Results posted: 2011-08-16

Locations

32 sites across 1 country: United States