A MULTICENTER, OPEN-LABEL PHARMACOKINETIC, PHARMACODYNAMIC, CLINICAL SYMPTOMS, AND SAFETY STUDY OF PANTOPRAZOLE DELAYED-RELEASED GRANULES ADMINISTERED AS A SUSPENSION IN NEONATES AND PRETERM INFANTS WITH A CLINICAL DIAGNOSIS OF GASTROESOPHAGEAL REFLUX DISEASE

Phase 3

• Conditions: gastroesophageal reflux; 10017969

• Registration Number: NL-OMON30569
• Lead Sponsor: Wyeth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

1. Male or female hospitalized patients admitted to a neonatal intensive care unit (NICU) or special care nursery, at the time of enrollment. 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 ( not older than 28 days), or be preterm infants with a corrected age of less than 44 weeks.4. Have a body weight of at least 1500 grams. 5. Patients must be able to tolerate oral feeding and swallow the test article.

Exclusion Criteria

1. Cardiovascular instability, life-threatening arrhythmia, previous cardiopulmonary arrest, or mechanical ventilation.2. Known 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. For PK Patients: History of treatment with PPIs within 24 hours before the first (1st) dose of test article.For PK/PD or PD Patients: History of treatment with PPIs within 7 days before the first (1st) dose of test article.7. For PK Patients: Use of histamine-2-receptor antagonists (H2RAs) within 24 hours before the first (1st) dose of test article. For PK/PD or PD Patients: Use of H2RAs within 3 days before the first (1st) dose of test article.8. Use of antacids within 2 hours before or after test article administration. Use of antacids is also prohibited 2 hours before or during pH-metry.9. 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.10. Significant renal or hepatic disease.11. Any life-threatening condition that would make it unlikely for the patient to be discharged from the hospital.12. Participation in any other investigational study within 30 days before the administration of test article without prior approval of the Wyeth Research, (WR) Medical Monitor.13. PD or PK/PD patients receiving 24-hour continuous enteral feeding or any feeding more frequently than every 3 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified