- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00539110
Differential Effects of Zolpidem Versus Ramelteon in Burned Children (Sleep3)
June 26, 2016 updated by: Michele Gottschlich, Shriners Hospitals for Children
Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Shriners Hospital for Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: zolpidem
zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
|
zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization
Other Names:
|
ACTIVE_COMPARATOR: ramelteon
ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization
|
ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polysomnography Data
Time Frame: 2 weeks postburn
|
Determine if intervention product elicits more total sleep time
|
2 weeks postburn
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics
Time Frame: 2 weeks postburn
|
evaluate the PK of zolpidem following standard dosing practices
|
2 weeks postburn
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michele M Gottschlich, PhD, Shriners Hospital for Children
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stockmann C, Spigarelli MG, Healy DP, Gottschlich MM, Kagan R, Balch AH, Sherwin C. Application of a method used to deconstruct a single dose pharmacokinetic profile from multiple dose data. Biopharm Drug Dispos. 2015 Sep;36(6):405-409. doi: 10.1002/bdd.1949. Epub 2015 Apr 21.
- Stockmann C, Gottschlich MM, Healy D, Khoury JC, Mayes T, Sherwin CM, Spigarelli MG, Kagan RJ. Relationship between zolpidem concentrations and sleep parameters in pediatric burn patients. J Burn Care Res. 2015 Jan-Feb;36(1):137-44. doi: 10.1097/BCR.0000000000000164.
- Stockmann C, Sherwin CM, Buterbaugh W, Spigarelli MG, Gottschlich MM, Healy D, Kagan RJ. Preliminary assessment of zolpidem pharmacokinetics in pediatric burn patients. Ther Drug Monit. 2014 Jun;36(3):295-301. doi: 10.1097/FTD.0000000000000017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
November 1, 2013
Study Registration Dates
First Submitted
October 2, 2007
First Submitted That Met QC Criteria
October 3, 2007
First Posted (ESTIMATE)
October 4, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
July 27, 2016
Last Update Submitted That Met QC Criteria
June 26, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 09-04-07-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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