Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00365300
First received: August 16, 2006
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  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
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  • Number of Patients Withdrawn From Study Due to Lack of Efficacy.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 June 18, 2013