NCT00539110

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 18, 2014

Completed
Last Updated

July 27, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

October 2, 2007

Results QC Date

May 25, 2014

Last Update Submit

June 26, 2016

Conditions

SleepBurns

Outcome Measures

Primary Outcomes (1)

  • Polysomnography Data

    Determine if intervention product elicits more total sleep time

    2 weeks postburn

Secondary Outcomes (1)

  • Pharmacokinetics

    2 weeks postburn

Study Arms (2)

zolpidem

EXPERIMENTAL

zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization

Drug: zolipidem

ramelteon

ACTIVE COMPARATOR

ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization

Drug: ramelteon

Interventions

zolipidemDRUG

zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization

Also known as: Ambien
zolpidem
ramelteonDRUG

ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization

Also known as: rozerem
ramelteon

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospital for Children

Cincinnati, Ohio, 45229, United States

Location

Related Publications (3)

  • 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.

    PMID: 25766031BACKGROUND

  • 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.

    PMID: 25185933BACKGROUND

  • 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.

    PMID: 24365985BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Zolpidemramelteon

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Michele Gottschlich PhD
Organization
Shriners Hospitals for Children
mgottschlich@shrinenet.org
513-872-6298

Study Officials

  • Michele M Gottschlich, PhD

    Shriners Hospital for Children

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Nutrition Services

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

December 1, 2009

Primary Completion

December 1, 2012

Study Completion

November 1, 2013

Last Updated

July 27, 2016

Results First Posted

September 18, 2014

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)