Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic GERD

This study has been completed.

First Received: August 16, 2006 Last Updated: November 30, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
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 Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

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Number of Patients Withdrawn From Study Due to Lack of Efficacy.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

Enrollment:	106
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
Pantoprazole: Active Comparator	Drug: pantoprazole
Placebo: Placebo Comparator	Other: Placebo

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365300

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

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

Keywords provided by Wyeth:

GERD
Infants
Gastroesophageal Reflux

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Pantoprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Esophageal Diseases
Gastroesophageal Reflux
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010