Status:
COMPLETED
Study Evaluating Pantoprazole in Children With GERD
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
- Subjects 6-11 years old unable to swallow tablets
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00141817
Start Date
August 1 2005
End Date
November 1 2007
Last Update
December 28 2011
Active Locations (23)
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1
Little Rock, Arkansas, United States, 72205
2
Orange, California, United States, 92868
3
San Diego, California, United States, 92103
4
Washington D.C., District of Columbia, United States, 20010