drugset / Trial / NCT00174928
A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.
Timeline
- Start
- 2005-05
- Primary completion
- 2005-08
- Completion
- 2005-08
Publications
- Results Springer M, Atkinson S, North J, Raanan M. Safety and pharmacodynamics of lansoprazole in patients with gastroesophageal reflux disease aged <1 year. Paediatr Drugs. 2008;10(4):255-63. doi: 10.2165/00148581-200810040-00004.
- Results Zhang W, Kukulka M, Witt G, Sutkowski-Markmann D, North J, Atkinson S. Age-dependent pharmacokinetics of lansoprazole in neonates and infants. Paediatr Drugs. 2008;10(4):265-74. doi: 10.2165/00148581-200810040-00005.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lansoprazole | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Lansoprazole | Other / unclassified | 1 mg/kg | Oral |