Differential Effects of Eszopiclone Versus Ramelteon in Burned Children - Tabular View

Tracking Information

First Received Date ^ICMJE

October 2, 2007

Last Updated Date

October 3, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

polysomnography data [ Time Frame: 2 weeks postburn ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00539110 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

hormone levels [ Time Frame: 2 weeks postburn ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Differential Effects of Eszopiclone Versus Ramelteon in Burned Children

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment

Condition ^ICMJE

Sleep
Burns

Intervention ^ICMJE

Drug: eszopiclone
Drug: ramelteon

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00539110

Responsible Party

Study ID Numbers ^ICMJE

Sleep III

Study Sponsor ^ICMJE

Shriners Hospitals for Children

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michele M Gottschlich

Shriners Hospital for Children

Information Provided By

Shriners Hospitals for Children

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP