Study Evaluating Pantoprazole in Adolescents With GERD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Gastroesophageal Reflux

Keywords

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Adolescents GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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3001A3-337

Identifier Type: -

Identifier Source: org_study_id