Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastroesophageal Reflux

In brief

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Key facts

Study ID

NCT00365300

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

129

Starts

2006-09-01

Expected to finish

2007-11-01

Last updated by the study team

2010-05-04

Who can join

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

You may qualify if…

• term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
• clinical diagnosis of GERD
• weight greater than 2.5 kg and less than or equal to 15 kg

You may not qualify if…

• known history of upper GI anatomic disorders
• history of acute life-threatening medical conditions
• clinically significant medical conditions or laboratory abnormalities

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Peoria, Illinois, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Flint, Michigan, United States
• Study site — Jackson, Mississippi, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Camden, New Jersey, United States
• Study site — Mays Landing, New Jersey, United States
• Study site — Morristown, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Buffalo, New York, United States
• Study site — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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