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

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ClinicalTrials.gov Identifier: NCT00539110
Recruitment Status : Completed
First Posted : October 4, 2007
Results First Posted : September 18, 2014
Last Update Posted : July 27, 2016
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children

Tracking Information
First Submitted Date  ICMJE October 2, 2007
First Posted Date  ICMJE October 4, 2007
Results First Submitted Date  ICMJE May 25, 2014
Results First Posted Date  ICMJE September 18, 2014
Last Update Posted Date July 27, 2016
Study Start Date  ICMJE December 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2014)
Polysomnography Data [ Time Frame: 2 weeks postburn ]
Determine if intervention product elicits more total sleep time
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2007)
Polysomnography Data [ Time Frame: 2 weeks postburn ]
Change History Complete list of historical versions of study NCT00539110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Pharmacokinetics [ Time Frame: 2 weeks postburn ]
evaluate the PK of zolpidem following standard dosing practices
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2007)
hormone levels [ Time Frame: 2 weeks postburn ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Differential Effects of Zolpidem Versus Ramelteon in Burned Children
Official Title  ICMJE Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
Brief Summary To examine sleep changes following therapeutic drug interventions designed to promote sleep.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep
  • Burns
Intervention  ICMJE
  • Drug: zolipidem
    zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization
    Other Name: Ambien
  • Drug: ramelteon
    ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
    Other Name: rozerem
Study Arms  ICMJE
  • Experimental: zolpidem
    zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
    Intervention: Drug: zolipidem
  • Active Comparator: ramelteon
    ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization
    Intervention: Drug: ramelteon
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2013)
10
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2007)
50
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00539110
Other Study ID Numbers  ICMJE 09-04-07-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michele Gottschlich, Shriners Hospitals for Children
Study Sponsor  ICMJE Shriners Hospitals for Children
Collaborators  ICMJE Children's Hospital Medical Center, Cincinnati
Investigators  ICMJE
Principal Investigator: Michele M Gottschlich, PhD Shriners Hospital for Children
PRS Account Shriners Hospitals for Children
Verification Date June 2016

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