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
Abstract
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.
Conditions: Gastroesophageal Reflux Disease.
Primary outcome: Pharmacokinetic Analysis.; Mean Intragastric 24 hour pH (subset of 6 subjects).
Enrollment: 24 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 24 participants or records.
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