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 - ND

• Conditions: CLINICAL DIAGNOSIS OF GASTROESOPHAGEAL REFLUX DISEASE GERD in neonates and preterm infants; MedDRA version: 9.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease

• Registration Number: EUCTR2006-001473-24-IT
• Lead Sponsor: Wyeth Pharmaceuticals Inc., Wyeth Research, Clinical Research and Development Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

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 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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified