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

This study has been completed.

First Received on August 16, 2006. Last Updated on April 26, 2010 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00365300

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Number of Patients Withdrawn From Study Due to Lack of Efficacy.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

Show 38 Study Locations

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 24, 2012