NCT00324974

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 1 Month – 11 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.

Detailed description

This study will be conducted by approximately 20 investigative sites in the U.S. and Poland. Participants 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).

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Lansoprazole microgranules suspension	Lansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks; Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks.
DRUG	Placebo	Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-05-11
• Last updated: 2010-07-22

Locations

17 sites across 2 countries: United States, Poland