Status:
COMPLETED
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
Nycomed
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
- Clinically significant medical or surgical abnormalities
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00259012
Start Date
November 1 2005
End Date
March 1 2008
Last Update
May 7 2010
Active Locations (31)
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1
Little Rock, Arkansas, United States, 72205
2
Loma Linda, California, United States, 92351
3
San Diego, California, United States, 92103
4
Washington D.C., District of Columbia, United States, 20010