Clinical diagnosis of gastroesophagal reflux disease (GERD) in neonates and preterm infants
Conditions
Sponsors
Wyeth Research, Clinical Research and Development, Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalized patients admitted to a neonatal intensive care unit (NICU) or special care nursery. 2. Have a clinical indication for acid suppression to treat a presumptive diagnosis of GERD based on clinical symptoms suggestive of GERD and/or objective tests diagnostic of GERD. NOTE: Disorders associated with or worsened by GERD, objective tests suggestive of GERD and/or aspiration in conjunction with GERD should also be noted. These are considered supportive documentation of the clinical diagnosis. 3. Be either term or post-term infants within the neonatal period (=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Cardiovascular instability, life-threatening arrhythmia, or previous cardiopulmonary arrest or mechanical ventilation. 2. Known history of human immunodeficiency virus (HIV) or clinical manifestations of acquired immune deficiency syndrome (AIDS) or other significant immunodeficiency disorder or malignancy. 3. Clinically significant laboratory test abnormality:a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >= 2 times upper limit of normal (ULN).b. Alkaline phosphatase >= 2 times ULN (age-corrected). 4. Known history of positive serologic test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or RNA. 5. Known hypersensitivity to proton pump inhibitors (PPIs), including pantoprazole. 6. History of treatment with PPIs (omeprazole, esomeprazole, lansoprazole, rabeprazole, or pantoprazole) within 24 hours before the first (1st) dose of test article. 7. Use of Histamine-2-receptor antagonist (H2RAs) (eg, cimetidine, famotidine, ranitidine, or nizatidine) within 24 hours before the first (1st) dose of test article. 8. Patients receiving continuous enteral feeding as a supplement to their oral feeding may not participate in the PD portion of the study.. 9. Use antiacids within 8 hours before test article administration on days 1 and 6 ± 1 as well as during days 1 and 6 ± 1. 10. Use of warfarin, carbamazepine, or phenytoin as well as rifampin for any disorder from at least 24 hours before the 1st dose of test article until after the final study procedure. 11. Significant renal or hepatic disease. 12. Any life-threatening condition that would make it unlikely for the patient to be discharged from the hospital. 13. Participation in any other investigational study within 30 days before the administration of test article without approval of the Wyeth Research medical monitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether or not consistent exposures can be achieved in neonates and preterm infants with presumed GERD receiving oral doses of pantoprazole;Secondary Objective: 1. To characterize the pharmacokinetics (PK) of oral pantoprazole after a single dose and at steady state when consistent exposures can be achieved in neonates and preterm infants with presumed GERD at doses expected to produce exposures similar to adults given standard doses. 2. To provide the pharmacodynamic assessment of pantoprazole after a single dose and at steady state by measurement of the pH of routinely collected pre-feeding gastric residuals in neonates and preterm infants with presumed GERD and an indwelling NG tube. 3. To characterize the change in clinical GERD and respiratory symptoms from baseline, after single-, multiple- doses of pantoprazole in neonates and preterm infants with presumed GERD. 4. To describe the safety of pantoprazole in neonates and preterm infants with presumed GERD throughout the study. ;Primary end point(s): Clinical Symptoms Evaluation Pharmacokinetics: - Single-dose PK Profiling - Multiple-dose PK Profiling Pharmakodynamics: -Single-dose PD Profiling - Multiple-dose PD Profiling | — |
Countries
Belgium, France, Italy, Netherlands
Outcome results
None listed