CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Xyrem (X) +3 moredrug
Likely dose
Xyrem (sodium oxybate) oral solution; Zolpidem 10 mg oral tablets; Modafinil oral tablets (dose not specified)AI-extracted
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓Confirmed obstructive sleep apnea syndrome per AASM criteria
  • ✓Apnea-Hypopnea Index (AHI) 10–40 with lowest O2 saturation ≥75%
  • ✓Willing and able to complete 6 nights in the sleep lab and entire protocol
Key exclusion· 9
  • ✕Sodium oxybate (GHB) use in the last 30 days
  • ✕Any investigational therapy within 30 days prior to screening
  • ✕Routine use of stimulants, sedative-hypnotics, tranquilizers, non-sedating antihistamines, benzodiazepines, clonidine, or anticonvulsants
  • ✕Regular alcohol consumption; must abstain for trial duration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00086281
NCT00086281Phase 4Completed
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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

Jazz Pharmaceuticals·interventional·Posted Jul 1, 2004·Updated Feb 24, 2012

In Brief

A Phase 4 clinical trial evaluating Xyrem (X), Zolpidem (Z), and 2 other interventions for Obstructive Sleep Apnea Syndrome. Completed, enrolled 60 participants across 2 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea Syndrome
CountriesCanada, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2004
Enrollment StartNov 1, 2003
Primary CompletionJun 1, 2005
Study CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 22.0 years ago

Interventions

Xyrem (X)drug

Xyrem (Sodium Oxybate) Oral Solution

Zolpidem (Z)drug

Zolpidem 10 mg oral tablets

Modafinil (M)drug

Modafinil Oral Tablets

Placebo (P)drug

Placebo Oral Solution