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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Drug: pantoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868296

3001B3-335

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Low dose

Active Comparator group

Treatment:

Drug: pantoprazole

High dose

Active Comparator group

Treatment:

Drug: pantoprazole