E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Soil-Transmitted Helminth Infections |
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E.1.1.2 | Therapeutic area | Diseases [C] - Parasitic Diseases [C03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
- Cure rate for A. lumbricoides for those participants with a positive egg count for that soil-transmitted helminth at baseline
-Cure rate for T. trichiura for those participants with a positive egg count for that soil-transmitted helminth at baseline
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E.5.1.1 | 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.
-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.
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E.5.2 | 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
-The percentage egg reduction for T. trichiura for those participants with a positive egg count for that soil-transmitted helminth at baseline |
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E.5.2.1 | 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%.
-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%. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 8 |