The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux

Inclusion Criteria:

• At least 7 days post-surgery at the time of Screening (Study Visit 1) with noanticipated need for surgery during the study.

• Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying during feeding, archingback, poor weight gain, or extraesophageal manifestations) or endoscopy proven refluxdisease.

• Must continue to have reflux symptoms during the Pretreatment Period despite reducingor eliminating exposure to tobacco smoke, using one positioning and feeding strategythe last 7 days as documented in the Daily Diary.

• The infant exhibited crying, fussing, or irritability during or within 1 hour offeeding in >25% of all feedings during the last 4 days of the Pretreatment Period asdocumented in the Daily Diary.

Exclusion Criteria:

• Body weight <2.0 kilogram at Dosing Day 1 of the Double-Blind Treatment Period.

• Unstable, congenital or acquired, clinically significant disease of any major organsystem (cardiovascular, respiratory, renal, hepatic, metabolic, etc.), includingsuspected and/or documented culture-proven sepsis.

• Coexisting esophageal disease (e.g., eosinophilic esophagitis, viral, bacterial orfungal infection) or caustic or physiochemical trauma to the esophagus.

• Any congenital anomaly of the upper gastric intestinal tract that might interfere withgastrointestinal motility, pH, absorption, or active or known history of necrotizingenterocolitis that has been surgically corrected.

• Use of a proton pump inhibitor within 30 days prior to Dosing Day 1.

• Use of H2 Blockers (i.e. Zantac) within 7 days prior to Dosing Day 1.

• Allergy to proton pump inhibitors (i.e. Prilosec, Prevacid).

• Use of prokinetics (e.g., metoclopramide) unless on a stable dose for at least 3 daysprior to entering the Pretreatment Period.

• Unable to obtain stable drug levels after continuous treatment with required drugsincluding theophylline derivatives, digoxin, phenytoin, phenobarbital, orcarbamazepine within the 7 days prior to Dosing Day 1.

• Clinically Significant abnormalities in clinical laboratory values.