Soil-transmitted helminth (STH) infections MedDRA version: 17.1 Level: LLT Classification code 10063126 Term: Worms System Organ Class: 100000004862
Conditions
Interventions
Trade Name: VERMOX
Product Name: VERMOX
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: MEBENDAZOLE
CAS Number: 31431-39-7
Other descriptive name: MEBENDAZOLE
Concentration unit: mg milligra
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Be an otherwise healthy child based on medical history, physical examination, vital signs, and concomitant medications and live in a high-prevalence area where parasite infection is endemic (ie, Prevalent in or peculiar to a particular locality, region, or people) - Have teeth and be able to chew the mebendazole chewable tablet - Girls must be premenarchal - Parent(s)/guardians of study 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 Are the trial subjects under 18? yes Number of subjects for this age range: 397 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
Exclusion criteria: - Have a history of clinically significant liver or renal insufficiency - cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (eg, anemia), rheumatologic, psychiatric, or metabolic disturbances that, in the opinion of the investigator, renders the candidate not suitable for mebendazole treatment - Have a suspected massive intestinal parasitic infection, based on history and physical findings, as determined by the principal investigator - Have any condition that, in the opinion of the investigator, would compromise the well-being of the study participant or the study or prevent the study participant from meeting or performing study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to assess the safety and tolerability of a mebendazole 500-mg chewable tablet formulation in a pediatric population (children 2 to 10 years of age, inclusive).;Secondary Objective: Not applicable;Primary end point(s): The number, severity, relationship to study drug, and type of adverse events reported.;Timepoint(s) of evaluation of this end point: Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in physical examination - Change in vital sign measurements;Timepoint(s) of evaluation of this end point: Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit | — |
Countries
Tanzania, United Republic of
Contacts
Public ContactClinical Registry Group-JB BV
Johnson & Johnson Pharmaceutical Research & Development
Outcome results
None listed