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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Lansoprazole microgranules suspension; Drug: Placebo

• Registration Number: NCT00324974
• Lead Sponsor: Takeda

Brief 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).

Study Timeline

• Study First Submitted: 2006-05-09
• Study First Submitted QC: 2006-05-09
• Study First Posted: 2006-05-11
• Study Start: 2006-06
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-20
• Last Update Posted: 2010-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lansoprazole QD	Lansoprazole microgranules suspension	-
Placebo QD	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	Week 4
Safety Assessments	Baseline through week 8

Secondary Outcome Measures

Name	Time	Method
Global Symptom Assessment, as answered by Investigator and Parent/Guardian	Baseline through Week 8
Sensitivity analyses of the primary endpoint	Week 4
Additional Daily Diary-based symptom Assessments	At the end of the double-blind treatment period and 30 days after the last dose of study drug.
Indicators of Growth Parameters	During and at the end of the Double-blind treatment period and 30 days after the last dose of study drug.