A Single-Blind, Randomised, Parallel-Group, Single-Centre Pharmacokinetic and pH-Monitoring Study of Esomeprazole in Infants up to 24 Months of Age

AstraZeneca AB0 个研究点目标入组 50 人开始时间: 2012年3月8日最近更新: 2012年3月20日

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•Inclusion criteria
•For inclusion in the study, subjects had to fulfil all of the following criteria:
•1.Age =1 months to =24 months.
•2.Able to ingest semisolid food if =3 months of age 3.Symptoms of GERD as judged by the investigator.
•4.Failed conservative therapy if =12 months old.
•5.Diagnosis confirmed by 24-hour pH-monitoring, the criteria being:
•a) =12 months old: reflux index (% time pH <4) of =5%
•b) >12 months old: reflux index (% time pH <4) of =5%.
•6.Informed consent signed by parent or guardian.
•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
•Any of the following was regarded as a criterion for exclusion from the study:
•1.Current or historical clinically significant illness that would, as judged by the investigator, be expected to interfere with the study procedures or with the metabolism of esomeprazole, or jeopardise the safety of the subject.
•2.Current or previous evidence of liver disease and necrotising enterocolitis.
•3.Receipt of experimental drug or use of experimental device within 8 weeks preceeding screening.
•4.History of resectional surgery of the esophagus, stomach, duodenum or jejunum.
•5.Use of any pharmacological antireflux therapy within 24 hours prior to the first dose of investigational product.
•6.Use of any proton pump inhibitor within 72 hours of the first dose of investigational product.
•7.Need for continuous concurrent therapy with anticholinergics, antineoplastic agents, H2-receptor antagonists, sucralfate, bismuth-containing compounds, methyl-xanthines (theophylline), pro-motility drugs, macrolide antibiotics or barbiturates.
•8.Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation (glycerol monostearate 40-55, hydroxypropylcellulose, hypromellose, magnesium stearate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent, polysorbate 80, sugar spheres, talc, triethyl citrate).
•9.Congenital drug addiction.
•10.Previous participation in the present study.

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