Status:
COMPLETED
A Safety Study of Mebendazole in Children 2 to 10 Years of Age
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
2-10 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the treatment of soil-tra...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT01173562
Start Date
February 1 2010
End Date
March 1 2010
Last Update
March 12 2014
Active Locations (1)
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1
Pemba, Tanzania