Status:

COMPLETED

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

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Gastroesophageal Reflux

Eligibility:

All Genders

1-12 years

Phase:

PHASE3

Brief Summary

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 (NCT0036260...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2008

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT00868296

Start Date

March 1 2006

End Date

March 1 2008

Last Update

May 4 2010

Active Locations (71)

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Page 1 of 18 (71 locations)

1

Phoenix, Arizona, United States, 85006

2

Loma Linda, California, United States, 92354

3

Oakland, California, United States, 94609-1809

4

Orange, California, United States, 92868