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NCT00383643 · ClinicalTrials.gov registry record · Phase 2
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
A Phase 2 study of Sleep Initiation and Maintenance Disorders, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT00383643: Completed Phase 2 study of Sleep Initiation and Maintenance Disorders, sponsored by Stanford University.
NCT00383643 is a Phase 2 study of Sleep Initiation and Maintenance Disorders that has completed, run by Stanford University. The registered enrollment target is 48 participants, below the 287-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00383643, a Phase 2 study of Sleep Initiation and Maintenance Disorders, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each of these two medications with placebos.
Primary Outcome
Clinician assessment of Clinical Global Impression-Change score at week 12 of treatment intervention. The Clinical Global Impression - Change scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the current time point. It is rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. One one clinician provided the
Conditions Studied
Interventions
- DRUG zolpidem tartrate
- DRUG sodium oxybate
- DRUG Matching Placebos
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2006-05 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00383643 record still lists
NCT00383643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 287-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Sleep Initiation and Maintenance Disorders appearing as the primary indexed condition, and to 3 interventions - of which zolpidem tartrate is the first listed.
NCT00383643 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00383643 about?
NCT00383643 is a clinical study titled "Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.". The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each of these two medications w...
What is the current status of trial NCT00383643?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2006-05. Estimated completion is 2009-12.
What conditions does trial NCT00383643 study?
This clinical trial studies the following conditions: Sleep Initiation and Maintenance Disorders.
What interventions are being tested in trial NCT00383643?
The interventions under investigation include: zolpidem tartrate (DRUG), sodium oxybate (DRUG), Matching Placebos (DRUG).
Who is sponsoring clinical trial NCT00383643?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00383643 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Initiation and Maintenance Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00383643's enrollment target sits among peer trials
48 17th of 19 higher than 3 of 19 other Sleep Initiation and Maintenance Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Initiation and Maintenance Disorders 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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