A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Infants With Clinically-Evident Gastroesophageal Reflux Disease.|
- Pharmacokinetic Analysis. [ Time Frame: Day 1 and 5 ] [ Designated as safety issue: No ]
- Mean Intragastric 24 hour pH (subset of 6 subjects) [ Time Frame: Day -1, 1 and 5 ] [ Designated as safety issue: No ]
- Gastroesophageal Reflux Disease Symptom Assessment. [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
|Experimental: Lansoprazole 1.0 mg/kg QD||
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
|Experimental: Lansoprazole 2.0 mg/kg QD||
Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.
A Phase 1, multicenter, pharmacokinetic/Pharmacodynamic and safety study in which infants will be randomized in an open-label fashion to receive 5 days of open-label treatment with lansoprazole pediatric suspension 1 mg/kg/day oral, or lansoprazole pediatric suspension 2 mg/kg/day oral. On Dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at Baseline, on Dosing Day 1 (or Day 2) and on Dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on Post-Dosing Day 14.