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

Overview[ - collapse ][ - ]

Purpose To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
ConditionGastroesophageal Reflux
InterventionDrug: pantoprazole
Drug: Placebo
PhasePhase 3
SponsorWyeth is now a wholly owned subsidiary of Pfizer
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov IdentifierNCT00365300
First ReceivedAugust 16, 2006
Last UpdatedApril 26, 2010
Last verifiedApril 2010

Tracking Information[ + expand ][ + ]

First Received DateAugust 16, 2006
Last Updated DateApril 26, 2010
Start DateSeptember 2006
Estimated Primary Completion DateNovember 2007
Current Primary Outcome MeasuresNumber of Patients Withdrawn From Study Due to Lack of Efficacy. [Time Frame: 4 weeks double-blind] [Designated as safety issue: No]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.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleStudy Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
Official TitleA 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.
Brief Summary
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic
Gastroesophageal Reflux Disease (GERD).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionGastroesophageal Reflux
InterventionDrug: pantoprazole
Drug: Placebo
Study Arm (s)
  • Active Comparator: Pantoprazole
  • Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment129
Estimated Completion DateNovember 2007
Estimated Primary Completion DateNovember 2007
Eligibility 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
GenderBoth
AgesN/A
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00365300
Other Study ID Numbers3001B3-329
Has Data Monitoring CommitteeNot Provided
Information Provided ByWyeth is now a wholly owned subsidiary of Pfizer
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Verification DateApril 2010

Locations[ + expand ][ + ]

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
United States, California
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
United States, Florida
Orlando, Florida, United States, 32801
United States, Florida
Pensacola, Florida, United States, 32504
United States, Florida
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
United States, Kentucky
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
United States, New Jersey
Mays Landing, New Jersey, United States, 08330
United States, New Jersey
Morristown, New Jersey, United States, 07962
United States, New York
Brooklyn, New York, United States, 11219
United States, New York
Buffalo, New York, United States, 14222
United States, New York
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
United States, Virginia
Richmond, Virginia, United States, 23219
United States, West Virginia
Huntington, West Virginia, United States, 25701
United States, West Virginia
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Madison, Wisconsin, United States, 53715