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NCT01173562 - 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

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


CSR Summary

Not Yet Available


Data Specification

Not Available


Annotated CRF

Not Available

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Product Info

Generic Name
Mebendazole
Product Name
VERMOX
Therapeutic Area
Parasitic Diseases
Enrollment
396
% Female
48.0%
% White
1.0%
Product Class
Antiparasitics
Sponsor Protocol Number
MEBENDAZOLGAI3002
Data Holder
Johnson & Johnson
Condition Studied
Healthy Volunteers
Mean/Median Age (Years)
4.6

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

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.