Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

Wyeth

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Drug: pantoprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365300

3001B3-329

Details and patient eligibility

About

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Enrollment: 129 patients

Sex: All

Ages: 28 days to 11 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
• clinical diagnosis of GERD
• weight greater than 2.5 kg and less than or equal to 15 kg

Exclusion criteria

• known history of upper GI anatomic disorders
• history of acute life-threatening medical conditions
• clinically significant medical conditions or laboratory abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 2 patient groups, including a placebo group

Pantoprazole

Active Comparator group

Treatment:

Drug: pantoprazole

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo