Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

Completed · Phase 3

Conditions studied: Gastroesophageal Reflux

In brief

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

Key facts

Study ID

NCT00259012

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

67

Starts

2005-11-01

Expected to finish

2008-03-01

Last updated by the study team

2010-05-07

Who can join

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

You may qualify if…

• Greater than 44 weeks beyond neonatal period but less than 12 months
• Presumptive diagnosis of GERD
• Weight greater than 2.5 kg but less than 15 kg

You may not qualify if…

• History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
• Clinically significant medical or surgical abnormalities

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Loma Linda, California, United States
• Study site — San Diego, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Jackson, Mississippi, United States
• Study site — Kansas City, Missouri, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Temple, Texas, United States
• Study site — Brisbane, Australia
• Study site — Antwerp, Belgium
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Paris, France
• Study site — Aachen, Germany
• Study site — Osnabrück, Germany
• Study site — Brescia, Italy
• Study site — Naples, Italy

Full record on ClinicalTrials.gov

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