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

Condition(s) targeted: Gastroesophageal Reflux Disease

Intervention: Lansoprazole Microgranules suspension (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: TAP Pharmaceutical Products Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: TAP Pharmaceutical Products Inc.

This study will assess the safety and efficacy of once daily administration of Lansoprazole Microgranules Oral Suspension in infants with gastroesophageal reflux symptoms during a 4-week treatment period.

Official title: A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment.

Safety Assessments

Secondary outcome:

Global Symptom Assessment, as answered by Investigator and Parent/Guardian

Sensitivity analyses of the primary endpoint

Additional Daily Diary-based symptom Assessments

Indicators of Growth Parameters

Detailed description: This study will be conducted by approximately 20 investigative sites in the U. S. and Poland. Subjects who qualify will be randomized in equal proportions to receive either lansoprazole Pediatric Suspension (0. 2-0. 3 mg/kg/day in infants <10 weeks of age or 1. 0-1. 5 mg/kg/day in infants >10 weeks of age) or Placebo. This study consists of three periods: Pretreatment Period of 7-14 days, Double-Blind Treatment Period of 4 weeks (Dosing), and the Post-Treatment Period of 30 days (Follow-Up).

Minimum age: 1 Month. Maximum age: 11 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- At least 7 days post-surgery at the time of Screening (Study Visit 1) with no

anticipated need for surgery during the study.

- Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or

"spitting up," fussing/irritability, feeding refusal, crying during feeding, arching back, poor weight gain, or extraesophageal manifestations) or endoscopy proven reflux disease.

- Must continue to have reflux symptoms during the Pretreatment Period despite reducing

or eliminating exposure to tobacco smoke, using one positioning and feeding strategy the last 7 days as documented in the Daily Diary.

- The infant exhibited crying, fussing, or irritability during or within 1 hour of

feeding in >25% of all feedings during the last 4 days of the Pretreatment Period as documented 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 organ

system (cardiovascular, respiratory, renal, hepatic, metabolic, etc.), including suspected and/or documented culture-proven sepsis.

- Coexisting esophageal disease (e. g., eosinophilic esophagitis, viral, bacterial or

fungal infection) or caustic or physiochemical trauma to the esophagus.

- Any congenital anomaly of the upper gastric intestinal tract that might interfere with

gastrointestinal motility, pH, absorption, or active or known history of necrotizing enterocolitis 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 days

prior to entering the Pretreatment Period.

- Unable to obtain stable drug levels after continuous treatment with required drugs

including theophylline derivatives, digoxin, phenytoin, phenobarbital, or carbamazepine within the 7 days prior to Dosing Day 1.

- Clinically Significant abnormalities in clinical laboratory values.

Bialystok, Poland

Cracow, Poland

Katowice, Poland

Lodz, Poland

Lublin, Poland

Rzeszow, Poland

Warsawa, Poland

Wroclaw, Poland

Tampa, Florida, United States

Park Ridge, Illinois, United States

Shreveport, Louisiana, United States

Flint, Michigan, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

Cincinnati, Ohio, United States

Youngstown, Ohio, United States

Vienna, Virginia, United States

For the Prevacid Package Insert, refer to this link:

For FDA Safety Alerts and Recalls, refer to this link:

Starting date: June 2006
Ending date: May 2007
Last updated: April 4, 2008