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

NCT ID: NCT00324974

Last Updated: 2010-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-05-31

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).

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lansoprazole QD

Group Type: EXPERIMENTAL

Lansoprazole microgranules suspension

Intervention Type: DRUG

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.

Placebo QD

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.

Interventions

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.

Intervention Type: DRUG

Placebo

Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 11 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Takeda Global Research & Development Center, Inc.

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

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

Bialystok, , Poland

Katowice, , Poland

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Rzeszów, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Countries

United States; Poland

References

Orenstein SR, Hassall E, Furmaga-Jablonska W, Atkinson S, Raanan M. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. J Pediatr. 2009 Apr;154(4):514-520.e4. doi: 10.1016/j.jpeds.2008.09.054. Epub 2008 Dec 3.

Reference Type: RESULT

PMID: 19054529 (View on PubMed)

Other Identifiers

2006-000957-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1114-2358

Identifier Type: REGISTRY

Identifier Source: secondary_id

P-GI05-109

Identifier Type: -

Identifier Source: org_study_id