Study Evaluating Pantoprazole in Children With GERD

Completed · Phase 3

Conditions studied: Gastroesophageal Reflux

In brief

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Key facts

Study ID

NCT00141817

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

41

Starts

2005-08-01

Expected to finish

2007-11-01

Last updated by the study team

2011-12-28

Who can join

Age: 1 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Endoscopically proven GERD diagnosed within 6 months before study entry.
• Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

You may not qualify if…

• History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
• Subjects 6-11 years old unable to swallow tablets

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Flint, Michigan, 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 — Cincinnati, Ohio, United States
• Study site — Memphis, Tennessee, United States
• Study site — Temple, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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