Official Title: “A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD”

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: pantoprazole sodium enteric-coated spheroid suspension
  • pediatric suspension taken daily x 7 days - 333; pediatric suspension taken daily x 6 weeks - 335

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Arm 1- Low Dose pantoprazole
• Active Comparator: 2
  • Arm 2- active drug - pantoprazole

Primary Measures

• Characterization of PK and PD profile of single and multiple doses of pantoprazole
  • Time Frame: 7 days
    Safety Issue?: No

Secondary Measures

• Assessment of safety and tolerability of pantoprazole
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Greater than 44 weeks beyond neonatal period but less than 12 months
• Presumptive diagnosis of GERD
• Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

• History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
• Clinically significant medical or surgical abnormalities

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 11 Months

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 September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259012

Study ID Number: 3001B3-333, 3001B3-335

ClinicalTrials.gov Identifier: NCT00259012

Health Authority: United States: Food and Drug Administration