Official Title: “A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)”

To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: pantoprazole sodium enteric-coated spheroid
  • pediatric spheriods taken daily x 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Arm 1- Low Dose pantoprazole
• Active Comparator: 2
  • Arm 2- Medium Dose pantoprazole
• Active Comparator: 3
  • Arm 3- High Dose pantoprazole

Primary Measures

• The primary efficacy outcome is the weekly GERD symptom score.
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Safety and Tolerability
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• individual mean frequency of each GERD symptom
  • Time Frame: 8 weeks
    Safety Issue?: No
• individual mean score for respiratory symptoms
  • Time Frame: 8 weeks
    Safety Issue?: No
• change in endoscopy results at end of study in patients with a second endoscopy
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• Ability to undergo endoscopy with required biopsy
• Ages 1 through 5 years
• Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.

Exclusion Criteria:

• History or presence of upper gastrointestinal anatomic or motor disorders
• Known current or active cow` s milk allergy
• Malignancy Other exclusions apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300755

Study ID Number: 3001B3-328

ClinicalTrials.gov Identifier: NCT00300755

Health Authority: United States: Food and Drug Administration