Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086281
Status:
COMPLETED
Last Update Posted:
2012-02-24
First Post:
2004-06-29
Brief Title:
Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
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
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None