A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
Condition: Helminth Infections
MeSH terms: Infections; Communicable Diseases; Helminthiasis
Intervention: Mebendazole; Placebo
Intervention description: Mebendazole will be administered as a single-dose 500 mg chewable tablet. For children 1 year to <36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.; Matching placebo will be administered as a single-dose chewable tablet. For children 1 year to <36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 295.0
Sex: All
Minimum age: 1 Year
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Helminth infections; Helminths; Pediatric; Preschool aged; School aged; Mebendazole; Vermox; Placebo

Summary:

      The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with
      placebo in pediatric participants with Helminth infections.
    

Eligibility criteria:

        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

        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