Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastroesophageal Reflux

In brief

The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

Key facts

Study ID

NCT00992589

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

344

Starts

2009-11-01

Expected to finish

2011-11-01

Last updated by the study team

2013-05-22

Who can join

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

You may qualify if…

• Diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD, based on frequent vomiting or regurgitation, with at least 1 of the following: a) poor weight gain, or b) irritability, excessive crying or disturbed sleep that both the parent(s) and the doctor consider abnormal (but not due to colic)
• or c) refusal to eat even if hungry or arching of the back during meals
• weight 2.5 kg to 15.0 kg
• I-GERQ-R score >16
• Have only 1 caregiver in addition to the parent(s)

You may not qualify if…

• History of confirmed acute life-threatening events due to GERD
• Known narrowing of the opening from the stomach to the small intestines
• Confirmed diagnosis of cow's milk allergy
• Have taken PPIs or H2-blockers (a class of drugs that inhibit stomach acid production) or any of several drugs that affect the normal movement of the digestive tract (caffeine, theophylline, antacids, erythromycin, and others) within 3 days before entering the study
• Have blood or urine test results that are well above or below the normal range for the infant

Where it is running

• Study site — Columbiana, Alabama, United States
• Study site — Dothan, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Bentonville, Arkansas, United States
• Study site — Orange, California, United States
• Study site — Centennial, Colorado, United States
• Study site — Thornton, Colorado, United States
• Study site — Maitland, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Owensboro, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Flint, Michigan, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Jackson, Mississippi, United States
• Study site — Bridgeton, Missouri, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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