Status:
COMPLETED
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
28-11 years
Phase:
PHASE3
Brief Summary
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
Eligibility Criteria
Inclusion
- 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
- known history of upper GI anatomic disorders
- history of acute life-threatening medical conditions
- clinically significant medical conditions or laboratory abnormalities
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00365300
Start Date
September 1 2006
End Date
November 1 2007
Last Update
May 4 2010
Active Locations (38)
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1
Mobile, Alabama, United States, 36604
2
Phoenix, Arizona, United States, 85016
3
Little Rock, Arkansas, United States, 72205
4
Oakland, California, United States, 94609