A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants

• Conditions: Helminth infections; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2016-000728-24-Outside-EU/EEA
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.;Secondary Objective: Not applicable;Primary end point(s): - Cure rate for A. lumbricoides for those participants with a positive egg count for that soil-transmitted helminth at baseline <br><br>-Cure rate for T. trichiura for those participants with a positive egg count for that soil-transmitted helminth at baseline<br><br><br><br>;Timepoint(s) of evaluation of this end point: -Baseline (Day 1) to Day 20 Cure is defined as a post treatment egg count of zero in participants who had a positive egg count at baseline.<br><br>-Baseline (Day 1) to Day 20 Cure is defined as a post treatment egg count of zero in participants who had a positive egg count at baseline.<br><br><br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -The percentage egg reduction for A. lumbricoides for those participants with a positive egg count for that soil-transmitted helminth at baseline<br><br>-The percentage egg reduction for T. trichiura for those participants with a positive egg count for that soil-transmitted helminth at baseline;Timepoint(s) of evaluation of this end point: -Baseline (Day 1) to Day 20 Egg count at end of treatment period minus egg count at baseline divided by egg count at baseline multiplied by 100%.<br><br>-Baseline (Day 1) to Day 20 Egg count at end of treatment period minus egg count at baseline divided by egg count at baseline multiplied by 100%.