Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

Wyeth

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Drug: pantoprazole sodium enteric-coated spheroid suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259012

3001B3-333, 3001B3-335

Details and patient eligibility

About

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

Enrollment: 67 patients

Sex: All

Ages: 1 to 11 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than 44 weeks beyond neonatal period but less than 12 months
• Presumptive diagnosis of GERD
• Weight greater than 2.5 kg but less than 15 kg

Exclusion criteria

• History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
• Clinically significant medical or surgical abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Low dose

Active Comparator group

Treatment:

Drug: pantoprazole sodium enteric-coated spheroid suspension

High dose

Active Comparator group

Treatment:

Drug: pantoprazole sodium enteric-coated spheroid suspension