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
  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:


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  • Number of Patients Withdrawn From Study Due to Lack of Efficacy.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014