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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Lansoprazole microgranules suspension
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 11 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lansoprazole QD<br> | Drug: Lansoprazole microgranules suspension<br>* 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.<br>|
| Placebo Comparator: Placebo QD<br> | Drug: Placebo<br>* Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux Disease, infant, lansoprazole oral suspension, PPI