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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 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.

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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.

Interventions

  • DRUG zolpidem tartrate
  • DRUG sodium oxybate
  • DRUG Matching Placebos

Study Locations (1)

California

  • Stanford University School of Medicine - Stanford

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2006-05
Est. Completion 2009-12
Phase Phase 2

Sponsor

Stanford University

1,744 total trials

What the Registry Record Tells You About NCT00383643

The ClinicalTrials.gov registry entry for NCT00383643 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 287-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (83% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.