A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive

Completed · Phase 1

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time), pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after single and multiple daily administration in infants between the ages of 1 and 11 months, inclusive, with Gastroesophageal Reflux Disease (GERD).

Key facts

Study ID

NCT00747526

Run by

Janssen Research & Development, LLC

People needed

51

Starts

2007-12-01

Expected to finish

2012-02-01

Last updated by the study team

2013-07-08

Who can join

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

You may qualify if…

• Minimum weight of 5 kg (treatment Option 1) or 3 kg (treatment Option 2) with a diagnosis of GERD
• Informed consent signed by at least one parent
• Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2 blockers, or antacids are eligible (as long as they can go off antacids for 24 hours, and PPIs and H2 blockers for three days prior to dosing, except for cimetidine, which must be discontinued for at least seven days prior to dosing) and remain off these medications for the treatment period

You may not qualify if…

• Patients who have history of or current clinically significant medical illness (excluding GERD) including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results
• Primary pulmonary or ears, nose, and throat (ENT) symptoms
• History of or current presence of peptic ulcers
• Presence of "warning signals", suggesting cause of vomiting/regurgitation other than GERD
• Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Oakland, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Maitland, Florida, United States
• Study site — Louisville, Kentucky, United States
• Study site — Jackson, Mississippi, United States
• Study site — Bridgeton, Missouri, United States
• Study site — Long Branch, New Jersey, United States
• Study site — Greenville, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Youngstown, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Antwerp, Belgium
• Study site — Brussels, Belgium
• Study site — São Paulo, Brazil
• Study site — Lublin, Poland
• Study site — Warsaw, Poland
• Study site — Barnsley, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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