Sleep3: Differential Effects of Zolpidem Versus Ramelteon in Burned Children

• Sponsor: Shriners Hospitals for Children (Other)
• Overall Status: Completed
• CT.gov ID: NCT00539110
• Collaborator: Children's Hospital Medical Center, Cincinnati (Other)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep; Burns	Drug: zolipidem; Drug: ramelteon	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: zolpidem zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization	Drug: zolipidem; zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization; Other Names: Ambien
Active Comparator: ramelteon ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization	Drug: ramelteon; ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization; Other Names: rozerem

Outcome Measures

Primary Outcome Measures

1. Polysomnography Data [2 weeks postburn]

   Determine if intervention product elicits more total sleep time

Secondary Outcome Measures

1. Pharmacokinetics [2 weeks postburn]

   evaluate the PK of zolpidem following standard dosing practices

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Shriners Hospital for Children	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Shriners Hospitals for Children
• Children's Hospital Medical Center, Cincinnati

Investigators

• Principal Investigator: Michele M Gottschlich, PhD, Shriners Hospital for Children

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Michele Gottschlich, Director, Nutrition Services, Shriners Hospitals for Children
• ClinicalTrials.gov Identifier: NCT00539110
• Other Study ID Numbers: 09-04-07-01
• First Posted: Oct 4, 2007
• Last Update Posted: Jul 27, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	Zolpidem First, Then Ramelteon	Ramelteon, Then Zolpidem
Arm/Group Description	medication dosed at 2200 and 0200 per feeding tube washout with no sleep meds (3 nights); zolpidem (x4 nights); washout (x3 nights); then ramelteon (x4 nights)	medication dosed at 2200 and 0200 per the feeding tube washout with no sleep meds (x3 nights); ramelteon (x4 nights); washout (x3 nights); then zolpidem (x 4 nights)
Period Title: Overall Study
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Zolpidem First, Then Ramelteon	Ramelteon First, Then Zolpidem	Total
Arm/Group Description	dosed at 2200 and 0200 per the feeding tube	dosed at 2200 and 0200 per the feeding tube	Total of all reporting groups
Overall Participants	5	5	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.8 (1.6)	7.8 (1.6)	7.8 (1.6)
Sex: Female, Male (Count of Participants)
Female	1 20%	4 80%	5 50%
Male	4 80%	1 20%	5 50%

Outcome Measures

1. Primary Outcome

Title	Polysomnography Data
Description	Determine if intervention product elicits more total sleep time
Time Frame	2 weeks postburn

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zolpidem	Ramelteon
Arm/Group Description	medication dosed at 2200 and 0200 per feeding tube	dosed at 2200 and 0200 per the feeding tube
Measure Participants	6	6
Mean (Standard Error) [minutes]	373 (40)	346 (33)

2. Secondary Outcome

Title	Pharmacokinetics
Description	evaluate the PK of zolpidem following standard dosing practices
Time Frame	2 weeks postburn

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Zolpidem		Ramelteon
Arm/Group Description	medication dosed at 2200 and 0200 per feeding tube zolipidem: dosed at 2200 and 0200 per feeding tube		dosed at 2200 and 0200 per the feeding tube ramelteon: medication dosed at 2200 and 0200 per feeding tube
All Cause Mortality
	Zolpidem		Ramelteon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Zolpidem		Ramelteon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Zolpidem		Ramelteon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.