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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 is a Phase 4 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 60 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00086281
The ClinicalTrials.gov registry entry for NCT00086281 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo (P) is the first listed.
NCT00086281 reports 0 study locations.
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.
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