A prospective open-label study on efficacy and tolerability of colloidal bismuth sub-citrate as adjunctive therapy to a combination of esomeprazole, amoxicillin and metronidazole for 10 days for Helicobacter pylori elimination in children. - Bismuth based quadruple therapy 10 days in children

Hôpital Universitaire Des Enfants Reine Fabiola0 个研究点目标入组 120 人开始时间: 2014年1月20日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•Paediatric subjects aged 6 to 17 years of either gender
•Body weight = 20kg
•H. pylori gastritis confirmed by positive histology and culture with antimicrobial susceptibility testing.
•Subject able to swallow tablets
•All girls of child-bearing potential must have a negative urine pregnancy test at Visit 1
•If sexually active, girls of child-bearing potential and boys whose partner is of child-bearing potential agree to use highly effective method of birth control during the trial.
•In the Investigator’s opinion, patient is willing and able to comply with all trial requirements specified in this protocol.
•Subjects (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically older than 11 years of age).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 120
•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

•Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
•Have a history of significant renal or hepatic impairment.
•Have an erosive esophagitis or peptic ulcer disease in the gastric or the duodenal mucosa.
•Have received proton pump inhibitors within 2 weeks prior to first administration of study agent.
•Have received any antimicrobial agent within 4 weeks prior to first administration of study agent.
•Require routine use (= 2 times per week) of non steroidal anti-inflammatory drug (NSAID)
•Are under any immunosuppressive agent
•Are under oral or IV steroids
•Scheduled elective surgery or any procedures requiring general anaesthesia during the trial.
•Known allergies or a known hypersensitivity to any Study Drugs or their excipients.
•Contraindication for any of the Study Drugs
•Any condition that, in the opinion of the Investigator, would compromise the well-being of the subject or the study or prevent the subject fromm meeting or performing study requirements.
•Participants who are participating or have participated in another study involving an investigational product in the past 12 weeks.

发起方

Hôpital Universitaire Des Enfants Reine Fabiola