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Study Evaluating Pantoprazole in Adolescents With GERD

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
pantoprazole
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Adolescents, GERD

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Assess the safety and tolerability of pantoprazole.

    Full Information

    First Posted
    August 21, 2006
    Last Updated
    December 7, 2007
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00367614
    Brief Title
    Study Evaluating Pantoprazole in Adolescents With GERD
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux
    Keywords
    Adolescents, GERD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    pantoprazole
    Primary Outcome Measure Information:
    Title
    Characterization of the PK profile of single and multiple doses of pantoprazole.
    Secondary Outcome Measure Information:
    Title
    Assess the safety and tolerability of pantoprazole.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating Pantoprazole in Adolescents With GERD

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