A Double-Blind, Randomized, Multi-Center, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Dose of a 500-mg Chewable Tablet of Mebendazole in the Treatment of Soil-Transmitted Helminth Infections (Ascaris lumbricoides and Trichuris trichiura) in Pediatric Subjects

Janssen Research & Development, LLC0 个研究点目标入组 240 人开始时间: 2016年3月1日最近更新: 2016年3月14日

适应症

试验速览

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•-Female participants who are >=9 years old must have a negative urine pregnancy test at screening or at the time of randomization
•-Participants must be an otherwise healthy child, based on medical history, physical examination, vital signs, hemoglobin, and concomitant medications
•-Participants >=3 years of age must have teeth and be able to chew
•-Participant must be available to return to the study site for all visits, including the follow-up visit
•-Parent(s)/guardians of participants (or their legally-accepted 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 have their child participate in the study
•-Children 6 years of age and older will be asked to assent (agree) to their participation using appropriate language to their level of understanding; assent will be documented.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 240
•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

•-Participant has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at screening or at the time of randomization
•-Participant has a significant medical disorder, participant has difficulty in chewing or swallowing
•-Participant has significant anemia (<8 g/dL) -Participant has significant wasting (greater than 2 standard deviations below the mean World Health Organization [WHO] Child Growth Standards for weight-for-height or body
•mass index)
•-Participant has a known hypersensitivity to mebendazole, any inert ingredients in the chewable formulation
•-Participant has preplanned surgery/procedures that would interfere with the conduct of the study during the course of study
•-Participants has received an investigational drug (including vaccines) or used an investigational medical device within 30 days before the planned start of treatment, or is currently enrolled in an investigational study
•-Employees of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
•-Participant has taken any form of medication containing mebendazole or any other treatment for soil transmitted helminth infection within 30 days of entry into the study

发起方