NCT00086281

Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients

Randomized, Placebo-Controlled Multicenter Trial of the Effects of Orally Administered Xyrem (Sodium Oxybate) and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).

Detailed description

This study will be conducted as a randomized, crossover study of the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DRUG	Xyrem (X)	Xyrem (Sodium Oxybate) Oral Solution
DRUG	Zolpidem (Z)	Zolpidem 10 mg oral tablets
DRUG	Modafinil (M)	Modafinil Oral Tablets
DRUG	Placebo (P)	Placebo Oral Solution

Timeline

• Start date: 2003-11-01
• Primary completion: 2005-06-01
• Completion: 2005-11-01
• First posted: 2004-07-01
• Last updated: 2012-02-24
• Results posted: 2012-02-24

Locations

2 sites across 2 countries: United States, Canada