Status:
COMPLETED
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
1-28 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
Eligibility Criteria
Inclusion
- Hospitalized patients
- Presumed diagnosis of GERD
- Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks
Exclusion
- cardiovascular instability
- clinically significant laboratory abnormalities
- use of warfarin, carbamazepine, phenytoin, or rifampin
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00362609
Start Date
July 1 2006
End Date
December 1 2007
Last Update
May 14 2010
Active Locations (71)
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1
Phoenix, Arizona, United States, 85006
2
Loma Linda, California, United States, 92354
3
Oakland, California, United States, 94609-1809
4
Orange, California, United States, 92868