Study Phase 3

An Open-Label, Single-Dose Study to Assess the Safety of 500-mg Mebendazole Chewable Formulation in Children 2 to 10 Years of Age, Inclusive

Trial Information

Generic NameMebendazoleProduct NameVERMOXTherapeutic AreaAntiparasitic Products, Insecticides, and RepellentsProduct ClassAnthelminticsPharmacological SubgroupAntinematodal AgentsChemical SubgroupBenzimidazole DerivativesCondition StudiedHealthy Volunteers
Sponsor Protocol NumberMEBENDAZOLGAI3002Enrollment396Data PartnerJohnson & Johnson% Female48.0%Mean/Median Age (Years)4.6% White1.0%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.