Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Wyeth

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Drug: pantoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362609

3001B3-331, 3001B3-335

Details and patient eligibility

About

The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.

Enrollment: 59 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized patients
• Presumed diagnosis of GERD
• Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks

Exclusion criteria

• cardiovascular instability
• clinically significant laboratory abnormalities
• use of warfarin, carbamazepine, phenytoin, or rifampin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

59 participants in 2 patient groups

Low dose

Active Comparator group

Treatment:

Drug: pantoprazole

High dose

Active Comparator group

Treatment:

Drug: pantoprazole