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

NCT00086281 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-02-24

Study results available
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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).

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Yanping Zheng, MD · Jazz Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2005-06-30
Completion
2005-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00086281 on ClinicalTrials.gov