Study Evaluating Pantoprazole in Adolescents With GERD

A Multicenter, Randomized, Open-Label, Single And Multiple Dose Study Of The Pharmacokinetics And Safety of Two Dose Levels of Pantoprazole Sodium Tablets In Adolescents Aged 12 Through 16 Years With A Clinical Daignosis Of GERD.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00367614

Enrollment

Registered

2006-08-23

Start date

2007-01-31

Completion date

2007-08-31

Last updated

2007-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Adolescents, GERD

Brief summary

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).

Interventions

DRUGpantoprazole

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Characterization of the PK profile of single and multiple doses of pantoprazole.	—

Secondary

Measure	Time frame
Assess the safety and tolerability of pantoprazole.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026