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.

Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development0 个研究点目标入组 56 人开始时间: 2007年7月24日最近更新: 2021年10月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 56

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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 requiring pharmacologic treatment. 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

排除标准

•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 may not have had PPIs for 7 days before baseline pH-metry.
•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 baseline pH-metry.
•10) Use of antacids is prohibited 2 hours before PK laboratory blood draws and/or 2 hours before and during 24 hour pH-metry procedures.
•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.
•18)Known or suspected infectious eophagitis.

研究者

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development

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