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”

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.

Study Type: Interventional

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

Study Primary Completion Date: May 2007

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).

Intervention(s) in this Clinical Trial

• Drug: Lansoprazole Microgranules suspension
  • 0.2-0.3mg/kg/day Suspension orally once daily for 28 days (infants<10weeks) 1.0-1.5mg/kg/day Suspension orally once daily for 28 days (infants>10weeks)
• Drug: Placebo
  • Suspension orally once daily for 28 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• 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.
  • Time Frame: Week 4
    Safety Issue?: No
• Safety Assessments
  • Time Frame: Baseline through week 8
    Safety Issue?: Yes

Secondary Measures

• Global Symptom Assessment, as answered by Investigator and Parent/Guardian
  • Time Frame: Baseline through Week 8
    Safety Issue?: No
• Sensitivity analyses of the primary endpoint
  • Time Frame: Week 4
    Safety Issue?: No
• Additional Daily Diary-based symptom Assessments
  • Time Frame: At the end of the double-blind treatment period and 30 days after the last dose of study drug.
    Safety Issue?: No
• Indicators of Growth Parameters
  • Time Frame: During and at the end of the Double-blind treatment period and 30 days after the last dose of study drug.
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 11 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Takeda Global Research & Development Center, Inc.

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair Takeda Global Research & Development Center, Inc.  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00324974

Study ID Number: P-GI05-109

ClinicalTrials.gov Identifier: NCT00324974

Health Authority: United States: Food and Drug Administration

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