Status:
COMPLETED
Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
28-11 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine how the body uses and eliminates pantoprazole, a drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much drug is in the blo...
Detailed Description
Gastroesophageal reflux, regurgitation of gastric contents into the esophagus, and gastroesophageal reflux disease, displaying symptoms and complications from regurgitation, are both very common in in...
Eligibility Criteria
Inclusion
- Signed informed consent and HIPAA documents by parent/legal guardian.
- Hospitalized premature neonates (Post menstrual age (PMA) 28 - \< 34 weeks), neonates (PMA 34 to 44 weeks), and infants (PMA \> 44 weeks to 11 months).
- Clinical indication for acid suppression or a presumptive diagnosis of GERD based on clinical symptoms and/or objective tests diagnostic of GERD.
- Body weight of at least 750 grams (based on blood volume required for study participation).
Exclusion
- Previous adverse reaction to proton pump inhibitor
- History of gastrointestinal anomalies, eosinophilic esophagitis, unrepaired tracheal esophageal fistula or liver disease
- Unstable cardiovascular, renal, hepatic, hematologic or endocrine disease
- History of acute life-threatening events due to GERD
- History of hepatitis B or hepatitis C
- Use of PPI's within 24 hours before study drug is administered
- Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome
- Clinically significant laboratory values:
- Aspartate aminotransferase (AST) or alanine aminotransferase (AST) \>2 times the upper limit of normal (ULN) for age
- Total bilirubin \> 2 times ULN for age
- Alkaline phosphatase \> 2 times ULN for age
- Use of histamine-2 receptor blockers (eg. Cimetidine, famotidine, ranitidine, or nizatidine) sucralfate, misoprostol, or prokinetic agents (eg. urecholine, erythromycin, or metoclopramide) and antacids or bismuth preparations within 24 hours before test article administration.
- Any disorder requiring chronic use of warfarin, oxcarbazepine, topiramate, carbamezapine, rifampin or phenytoin.
- Currently participating in another investigational drug trial or have participated in a study within the last 30 days.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00744419
Start Date
May 1 2009
End Date
April 1 2012
Last Update
December 3 2015
Active Locations (1)
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1
University of Louisville Research Foundation, Inc/KCPCRU
Louisville, Kentucky, United States, 40202