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

Purpose

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

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: pantoprazole Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole sodium

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Number of Patients Withdrawn From Study Due to Lack of Efficacy.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.

Enrollment:	129
Study Start Date:	September 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Pantoprazole	Drug: pantoprazole
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	up to 11 Months
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00365300 History of Changes
Other Study ID Numbers:	3001B3-329
Study First Received:	August 16, 2006
Results First Received:	November 30, 2009
Last Updated:	April 26, 2010
Health Authority:	United States: Food and Drug Administration

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

Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013