Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

Completed · Phase 3

Conditions studied: Gastroesophageal Reflux

In brief

The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.

Key facts

Study ID

NCT00868296

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

58

Starts

2006-03-01

Expected to finish

2008-03-01

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…

• Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study.

You may not qualify if…

• Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

Where it is running

• Study site — Loma Linda, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — New Haven, Connecticut, 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 — Sunrise, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Flint, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Camden, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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