Study Evaluating Pantoprazole in Adolescents With GERD
December 7, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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.
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 Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Characterization of the PK profile of single and multiple doses of pantoprazole.
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Secondary Outcome Measures
Outcome Measure |
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Assess the safety and tolerability of pantoprazole.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
August 21, 2006
First Submitted That Met QC Criteria
August 21, 2006
First Posted (Estimate)
August 23, 2006
Study Record Updates
Last Update Posted (Estimate)
December 10, 2007
Last Update Submitted That Met QC Criteria
December 7, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3001A3-337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.