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Trial record 37 of 121 for:    ZOLPIDEM AND Central Nervous System Depressants

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Sleep
Burns
Interventions Drug: zolipidem
Drug: ramelteon
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zolpidem First, Then Ramelteon Ramelteon, Then Zolpidem
Hide 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
Arm/Group Title Zolpidem First, Then Ramelteon Ramelteon First, Then Zolpidem Total
Hide 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 Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
There were ten patients total, crossover design, so each of the 10 patients received both zolpidem and ramelteon. Mean age 7.8 years
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
7.8  (1.6) 7.8  (1.6) 7.8  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
1
  20.0%
4
  80.0%
5
  50.0%
Male
4
  80.0%
1
  20.0%
5
  50.0%
1.Primary Outcome
Title Polysomnography Data
Hide Description Determine if intervention product elicits more total sleep time
Time Frame 2 weeks postburn
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem Ramelteon
Hide Arm/Group Description:
medication dosed at 2200 and 0200 per feeding tube
dosed at 2200 and 0200 per the feeding tube
Overall Number of Participants Analyzed 6 6
Mean (Standard Error)
Unit of Measure: minutes
373  (40) 346  (33)
2.Secondary Outcome
Title Pharmacokinetics
Hide Description evaluate the PK of zolpidem following standard dosing practices
Time Frame 2 weeks postburn
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem Ramelteon
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem Ramelteon
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem Ramelteon
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michele Gottschlich PhD
Organization: Shriners Hospitals for Children
Phone: 513-872-6298
Responsible Party: Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00539110     History of Changes
Other Study ID Numbers: 09-04-07-01
First Submitted: October 2, 2007
First Posted: October 4, 2007
Results First Submitted: May 25, 2014
Results First Posted: September 18, 2014
Last Update Posted: July 27, 2016