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Differential Effects of Zolpidem Versus Ramelteon in Burned Children (Sleep3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539110
First Posted: October 4, 2007
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
  Purpose
To examine sleep changes following therapeutic drug interventions designed to promote sleep.

Condition Intervention Phase
Sleep Burns Drug: zolipidem Drug: ramelteon Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings

Resource links provided by NLM:


Further study details as provided by Michele Gottschlich, Shriners Hospitals for Children:

Primary Outcome Measures:
  • Polysomnography Data [ Time Frame: 2 weeks postburn ]
    Determine if intervention product elicits more total sleep time


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 weeks postburn ]
    evaluate the PK of zolpidem following standard dosing practices


Enrollment: 10
Study Start Date: December 2009
Study Completion Date: November 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zolpidem
zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
Drug: zolipidem
zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization
Other Name: Ambien
Active Comparator: ramelteon
ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization
Drug: ramelteon
ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
Other Name: rozerem

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Burn injury > 20% total body surface area
  • Between 3 and 18 years of age
  • < 7 days from acute injury
  • Written informed consent and HIPPA release signed

Exclusion Criteria:

  • Suspected anoxic brain injury or head injury
  • Hepatic or endocrine disease
  • History of alcoholism or substance abuse
  • Pre-existing neurological or primary psychiatric disorder
  • Medical history of pre-existing sleep disorder or lactose deficiency
  • Questionable survival (<72 hrs) as decided by PI
  • Receipt of drugs with known effects on sleep within 24 hrs of study entry
  • No informed consent/HIPPA release
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539110


Locations
United States, Ohio
Shriners Hospital for Children
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Shriners Hospitals for Children
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Michele M Gottschlich, PhD Shriners Hospital for Children
  More Information

Publications:
Responsible Party: Michele Gottschlich, Director, Nutrition Services, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00539110     History of Changes
Other Study ID Numbers: 09-04-07-01
First Submitted: October 2, 2007
First Posted: October 4, 2007
Results First Submitted: May 25, 2014
Results First Posted: September 18, 2014
Last Update Posted: July 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action