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Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

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ClinicalTrials.gov Identifier: NCT00365300
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : January 7, 2010
Last Update Posted : May 4, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: pantoprazole Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.
Study Start Date : September 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Pantoprazole Drug: pantoprazole
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of Patients Withdrawn From Study Due to Lack of Efficacy. [ Time Frame: 4 weeks double-blind ]
    Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.



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Ages Eligible for Study:   up to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
  • clinical diagnosis of GERD
  • weight greater than 2.5 kg and less than or equal to 15 kg

Exclusion Criteria:

  • known history of upper GI anatomic disorders
  • history of acute life-threatening medical conditions
  • clinically significant medical conditions or laboratory abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365300


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Locations
United States, Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Phoenix, Arizona, United States, 85016
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Oakland, California, United States, 94609
Orange, California, United States, 92868
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Miami, Florida, United States, 33101
Orlando, Florida, United States, 32801
Pensacola, Florida, United States, 32504
Tampa, Florida, United States, 33606
United States, Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Peoria, Illinois, United States, 61603
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Flint, Michigan, United States, 48503
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Nebraska
Omaha, Nebraska, United States, 68105
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Camden, New Jersey, United States, 08103
Mays Landing, New Jersey, United States, 08330
Morristown, New Jersey, United States, 07962
United States, New York
Brooklyn, New York, United States, 11219
Buffalo, New York, United States, 14222
Valhalla, New York, United States, 10595
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18017
United States, Tennessee
Memphis, Tennessee, United States, 38103
United States, Texas
Temple, Texas, United States, 76508
United States, Utah
Salt Lake City, Utah, United States, 84113
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Norfolk, Virginia, United States, 23507
Richmond, Virginia, United States, 23219
United States, West Virginia
Huntington, West Virginia, United States, 25701
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00365300     History of Changes
Other Study ID Numbers: 3001B3-329
First Posted: August 17, 2006    Key Record Dates
Results First Posted: January 7, 2010
Last Update Posted: May 4, 2010
Last Verified: April 2010

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
GERD
Infants
Gastroesophageal Reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action