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

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease

In brief

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.

Key facts

Study ID

NCT00324974

Run by

Takeda

People needed

162

Starts

2006-06-01

Expected to finish

2007-05-01

Last updated by the study team

2010-07-22

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Tampa, Florida, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Flint, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Buffalo, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Youngstown, Ohio, United States
• Study site — Vienna, Virginia, United States
• Study site — Bialystok, Poland
• Study site — Cracow, Poland
• Study site — Katowice, Poland
• Study site — Lodz, Poland
• Study site — Lublin, Poland
• Study site — Rzeszów, Poland
• Study site — Warsaw, Poland
• Study site — Wroclaw, Poland

Full record on ClinicalTrials.gov

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