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NCT00086281 · ClinicalTrials.gov registry record · Phase 4
Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
A Phase 4 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00086281: Completed Phase 4 study, sponsored by Jazz Pharmaceuticals.
NCT00086281 is a Phase 4 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00086281, a Phase 4 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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).
Primary Outcome
The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting \>= 10 seconds, accompanied by oxygen desaturation of \>3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting \>= 10 seconds, with clear decrease (\>50%) from baseline in the amplitude of breathing or a decrease \<50% in the amplitude o
Interventions
- DRUG Placebo (P)
- DRUG Xyrem (X)
- DRUG Zolpidem (Z)
- DRUG Modafinil (M)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2003-11 |
| Est. Completion | 2005-11 |
| Phase | Phase 4 |
What the finished NCT00086281 record still lists
NCT00086281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo (P) is the first listed.
NCT00086281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00086281 about?
NCT00086281 is a clinical study titled "Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients". 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).
What is the current status of trial NCT00086281?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2003-11. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00086281?
The interventions under investigation include: Placebo (P) (DRUG), Xyrem (X) (DRUG), Zolpidem (Z) (DRUG), Modafinil (M) (DRUG).
Who is sponsoring clinical trial NCT00086281?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00086281's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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