Trial Outcomes & Findings for Differential Effects of Zolpidem Versus Ramelteon in Burned Children (NCT NCT00539110)
NCT ID: NCT00539110
Last Updated: 2016-07-27
Results Overview
Determine if intervention product elicits more total sleep time
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
2 weeks postburn
Results posted on
2016-07-27
Participant Flow
Participant milestones
| Measure |
Zolpidem First, Then Ramelteon
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)
|
Ramelteon, Then Zolpidem
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)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Differential Effects of Zolpidem Versus Ramelteon in Burned Children
Baseline characteristics by cohort
| Measure |
Zolpidem First, Then Ramelteon
n=5 Participants
dosed at 2200 and 0200 per the feeding tube
|
Ramelteon First, Then Zolpidem
n=5 Participants
dosed at 2200 and 0200 per the feeding tube
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.8 years
STANDARD_DEVIATION 1.6 • n=99 Participants
|
7.8 years
STANDARD_DEVIATION 1.6 • n=107 Participants
|
7.8 years
STANDARD_DEVIATION 1.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeks postburnDetermine if intervention product elicits more total sleep time
Outcome measures
| Measure |
Zolpidem
n=6 Participants
medication dosed at 2200 and 0200 per feeding tube
|
Ramelteon
n=6 Participants
dosed at 2200 and 0200 per the feeding tube
|
|---|---|---|
|
Polysomnography Data
|
373 minutes
Standard Error 40
|
346 minutes
Standard Error 33
|
SECONDARY outcome
Timeframe: 2 weeks postburnevaluate the PK of zolpidem following standard dosing practices
Outcome measures
Outcome data not reported
Adverse Events
Zolpidem
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ramelteon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michele Gottschlich PhD
Shriners Hospitals for Children
Phone: 513-872-6298
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place