A Safety Study of Mebendazole in Children 2 to 10 Years of Age

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Jul 29, 2010

Keywords

ClinConnect Summary

This is an open-label (identity of study drug will be known to study participant and investigator), single-center, single-dose, single-arm (ie, 1 treatment group) safety study. This study will consist of a screening visit on Day 1 at which time all study-related screening procedures will be performed. After all results are reviewed, children who meet all of the inclusion criteria and none of the exclusion criteria will be entered into the open-label phase of the study. A single mebendazole 500-mg chewable tablet will be administered on Day 1 and the children will remain at the study site so...

Gender

ALL

Eligibility 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
• 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