drugset / Trial / NCT00539110
Differential Effects of Zolpidem Versus Ramelteon in Burned Children
Phase 2
Completed
10 enrolled
Shriners Hospitals for Children
Children's Hospital Medical Center, Cincinnati · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
Timeline
- Start
- 2009-12
- Primary completion
- 2012-12
- Completion
- 2013-11
Publications
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ramelteon | Unknown | — | Other |
| Subject | Zolpidem | Small molecule | — | Other |
Indications
No indication recorded.