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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: pantoprazole

Primary Measures

• To assess the efficacy of pantoprazole in infants. The difference in withdrawal rates will be compared between the treatment and placebo groups.

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

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on August 29, 2008

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