Study Evaluating Pantoprazole in Adolescents With GERD

Wyeth is now a wholly owned subsidiary of Pfizer20 enrolled

Overview

The purpose of this study is characterize the PK profile of single and multiple doses of pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux

Interventions

pantoprazoleDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 12-16 years old * clinical diagnosis of GERD * ability to swallow tablets Exclusion Criteria: * GI or malabsorption disorders * chronic use of warfarin * positive pregnancy test

Outcomes

Primary Outcomes

Characterization of the PK profile of single and multiple doses of pantoprazole.

Secondary Outcomes

Assess the safety and tolerability of pantoprazole.

Data from ClinicalTrials.gov

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