Study Evaluating Pantoprazole in Children With GERD

Last updated: November 23, 2011
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT00141817
3001B3-334
B1791059
  • Ages 1-11
  • All Genders

Study Summary

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Endoscopically proven GERD diagnosed within 6 months before study entry.

  • Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight mustbe equal to or under 25 kg

Exclusion

Exclusion Criteria:

  • History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption,Eosinophilic esophagitis

  • Subjects 6-11 years old unable to swallow tablets

Study Design

Total Participants: 41
Study Start date:
August 01, 2005
Estimated Completion Date:
November 30, 2007

Connect with a study center

  • Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Orange, California 92868
    United States

    Site Not Available

  • San Diego, California 92103
    United States

    Site Not Available

  • Washington, District of Columbia 20010
    United States

    Site Not Available

  • Gainesville, Florida 32610
    United States

    Site Not Available

  • Miami, Florida 33101
    United States

    Site Not Available

  • Pensacola, Florida 32504
    United States

    Site Not Available

  • Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Louisville, Kentucky 40202
    United States

    Site Not Available

  • Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brockton, Massachusetts 02302
    United States

    Site Not Available

  • Detroit, Michigan 48201
    United States

    Site Not Available

  • Flint, Michigan 48503
    United States

    Site Not Available

  • Jackson, Mississippi 39216
    United States

    Site Not Available

  • Kansas City, Missouri 64108
    United States

    Site Not Available

  • New York, New York 10032
    United States

    Site Not Available

  • Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Memphis, Tennessee 38105
    United States

    Site Not Available

  • Temple, Texas 76508
    United States

    Site Not Available

  • Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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