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Differential Effects of Zolpidem Versus Ramelteon in Burned Children

NCT00539110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-07-27

Study results available
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Summary

To examine sleep changes following therapeutic drug interventions designed to promote sleep.

Conditions

  • Sleep
  • Burns

Interventions

DRUG

zolipidem

zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization

DRUG

ramelteon

ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Shriners Hospitals for Children

    lead OTHER

Principal Investigators

  • Michele M Gottschlich, PhD · Shriners Hospital for Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-12-31
Completion
2013-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00539110 on ClinicalTrials.gov