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Differential Effects of Eszopiclone Versus Ramelteon in Burned Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Shriners Hospitals for Children.   Recruitment status was  Not yet recruiting

First Received on October 2, 2007.   Last Updated on October 3, 2007   History of Changes
Sponsor: Shriners Hospitals for Children
Information provided by: Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00539110
  Purpose

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


Condition Intervention
Sleep
Burns
 Drug: eszopiclone
Drug: ramelteon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:

MedlinePlus related topics: Burns
Drug Information available for: Eszopiclone Ramelteon
U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • polysomnography data [ Time Frame: 2 weeks postburn ]

Secondary Outcome Measures:
  • hormone levels [ Time Frame: 2 weeks postburn ]

Estimated Enrollment: 50
  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539110

Contacts
Contact: Michele M Gottschlich, PhD, RD, CNSD 513-872-6298 mgottschlich@shrinenet.org
Contact: Theresa Mayes, BS, RD 513-872-6043 tmayes@shrinenet.org

Locations
United States, Ohio
Shriners Hospital for Children Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michele M Gottschlich, PhD, RD, CNSD     513-872-6298     mgottschlich@shrinenet.org    
Contact: Theresa Mayes, BS, RD     513-872-6043     tmayes@shrinenet.org    
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Michele M Gottschlich Shriners Hospital for Children
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00539110     History of Changes
Other Study ID Numbers: Sleep III
Study First Received: October 2, 2007
Last Updated: October 3, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012



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