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

Verified by: Wyeth is now a wholly owned subsidiary of Pfizer, April 2010
First Received: August 16, 2006 | Last Updated: April 26, 2010 | Phase: Phase 3 | Start Date: September 2006
Overall Status: Completed | Estimated Enrollment: 129
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To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD)...

Brief Summary

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.”

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

  • 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
  • Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

  • Drug: pantoprazole
  • Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Pantoprazole
  • Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of Patients Withdrawn From Study Due to Lack of Efficacy.
    • Time Frame: 4 weeks double-blind
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 11 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00365300

Study ID Number: 3001B3-329

ClinicalTrials.gov Identifier: NCT00365300

Health Authority: United States: Food and Drug Administration

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