NCT00367614

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 10, 2007

Status Verified

December 1, 2007

First QC Date

August 21, 2006

Last Update Submit

December 7, 2007

Conditions

Gastroesophageal Reflux

Keywords

AdolescentsGERD

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Assess the safety and tolerability of pantoprazole.

Interventions

pantoprazoleDRUG

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • clinical diagnosis of GERD
  • ability to swallow tablets

You may not qualify if:

  • GI or malabsorption disorders
  • chronic use of warfarin
  • positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 23, 2006

Study Start

January 1, 2007

Study Completion

August 1, 2007

Last Updated

December 10, 2007

Record last verified: 2007-12