A MULTICENTER, RANDOMIZED, OPEN LABEL, SINGLE AND MULTIPLE DOSE STUDY OF THE PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSE LEVELS OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED 1 THROUGH 11 MONTHS WITH PRESUMED GERD - ND
- Conditions
- INFANTS AGED 1 THROUGH 11 MONTHS WITH PRESUMED GERDMedDRA version: 9.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease
- Registration Number
- EUCTR2006-001132-45-IT
- Lead Sponsor
- Wyeth Pharmaceuticals Inc., Wyeth Research Div., Clinical research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 56
1 Male or female term or post term infants beyond the neonatal period 44 weeks but 12 months of age, or preterm infants with a corrected age of at least 44 weeks but 12 months at the time the informed consent is signed. 2 Have a presumptive diagnosis of GERD. The method used for the diagnosis of presumptive GERD will be recorded. 3 Weight must be 2.5 kg and 15 kg. 4 The patients may be hospitalized patients or outpatients at the time of study entry. 5 Patients must be able to swallow the suspension.
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
1 History of any of the following gastrointestinal disorders a Unrepaired tracheal esophageal fistula; b Gastrointestinal malabsorption. 2 Clinically significant medical or surgical abnormalities during the prestudy screening period physical examination, electrocardiogram ECG , or laboratory test, as assessed by the investigator. This includes a Unstable cardiovascular, renal, hepatic, hematologic, or endocrine disease except with prior approval of Wyeth medical monitor. b Active childhood infectious diseases eg, measles, mumps, or chickenpox .c Known coagulation disorders eg, hemophilia . 3 Known history of human immunodeficiency virus HIV or clinical manifestations of acquired immune deficiency syndrome AIDS or other immunodeficiency disorder. 4 Presence of terminal malignancy or any malignancy requiring treatment with radiation or chemotherapy within the past 6 months or if such treatment is planned within 30 days after the start of test article.5 Clinically significant laboratory abnormality of the following laboratory tests a Aspartate aminotransferase AST or alanine aminotransferase ALT 2 times upper limit of normal ULN .b Total bilirubin 2mg/dL.c Alkaline phosphatase 2 times ULN age corrected . 6 Known positive serologic test results for hepatitis B virus antigen HBsAg or hepatitis C virus HCV antibody or RNA . 7 Known hypersensitivity to proton pump inhibitors PPIs , including pantoprazole. 8 PK Portion History of treatment with PPIs within 24 hours before test article administration. PD or PK/PD Portion Patients undergoing PD assessments collection may not have had PPIs for 7 days before first test article administration. 9 PK Portion Use of histamine 2 receptor blockers H2RAs ,within 24 hours before test article administration PD or PK/PD Note Patients undergoing PD assessments may not have had H2RAs for 3 days before first test article administration. 10 Antacids are prohibited 2 hours before and after test article and 2 hours prior or during pH-metry. 11 Sucralfate, bismuth preparations, misoprostil or prokinetic agents should be discontinued 24 hours before test article administration. 12 Any disorder requiring chronic every day use of warfarin, carbamazepine, or phenytoin. 13 Participation in any other investigational drug trial or experimental trial within 30 days before administration of test article without approval from the Wyeth medical monitor. 14 History of recent acute-life threatening events due to manifestations of GERD. 15 Patient or PARENT felt to be unable to comply with study procedures in the investigator s opinion. 16 Continuous enteral feeding or any feeding more frequently than every 3 hours is prohibited in patients participating in PD or PK/PD portion of the study. 17 Use of special diets or herbal or alternative medication that might affect the metabolism of test article without prior approval of the Wyeth medical monitor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To characterize the PK profile of single and repeated doses of pantoprazole and the PD profile at baseline and at steady state in infants aged 1 through 11 months with presumed GERD.;Secondary Objective: To assess the safety and tolerability of pantoprazole in infants aged 1 through 11 months with presumed GERD.;Primary end point(s): Pharmacokinetics Single dose PK assessments will be performed after the first dose of test article. Multiple dose PK will be assessed on day 7 2 of test article administration after a least 5 consecutive but not more than 10 doses of test article. Pharmacodynamics The PD assessments will occur at baseline and at steady state after at least five consecutive but not more than 10 doses by measurement of intragastric and intraesophageal pH for up to 24hours. pH-metry will be used to define the PD of Pantoprazoloe in this patient population.
- Secondary Outcome Measures
Name Time Method