Official Title: “A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD.”

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: pantoprazole for approximately 9 weeks.

Primary Measures

• Characterization of the PK profile of single and multiple doses of pantoprazole.

Secondary Measures

• Assessment of safety and tolerability of pantoprazole and assessment of growth parameters

Inclusion Criteria:

• Endoscopically proven GERD diagnosed within 6 months before study entry.
• Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Exclusion Criteria:

• History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
• Subjects 6-11 years old unable to swallow tablets

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 11 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 November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00141817

Study ID Number: 3001B3-334

ClinicalTrials.gov Identifier: NCT00141817

Health Authority: United States: Food and Drug Administration