{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T07:35:08Z","timestamp":1791272108054,"version":"4.1.0"},"reference-count":15,"publisher":"Hindawi Limited","license":[{"start":{"date-parts":[[2012,1,1]],"date-time":"2012-01-01T00:00:00Z","timestamp":1325376000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Tropical Medicine"],"published-print":{"date-parts":[[2012]]},"abstract":"<jats:p>The primary objective was to evaluate the safety and tolerability of the new chewable formulation of mebendazole to treat soil-transmitted helminth (STH) infections in children \u226410 years old with the goal of using this formulation in preventive chemotherapy programs and expand treatment to young children who are unable to swallow solid tablets. In this open-label, single-arm, phase 3 study conducted at Pemba Island, Zanzibar, Tanzania, children aged 2 to 10 years (median age: 4 years) were administered a single dose of the mebendazole 500\u2009mg chewable tablet. Safety was assessed 30 minutes after dose and 3 days later. Of the 390 (98%) children who completed the study, 195 (55%) had \u22651 STH infection and 157 (45%) had no infection at baseline. The most common STH infections were<jats:italic>Trichuris trichiura<\/jats:italic>(51%), hookworm (16%), and<jats:italic>Ascaris lumbricoides<\/jats:italic>(7%). Treatment-emergent adverse events (TEAEs) were experienced by 11% of children. There was no difference in the percentage of children experiencing TEAEs between the age strata of 2\u20135 years and 6\u201310 years. Diarrhea was reported only in children aged 2\u20135 years. No correlation was observed between the type or percentage of AEs and presence or severity of infection. A single dose of mebendazole 500\u2009mg chewable tablet was safe and well tolerated in children aged 2 to 10 years.<\/jats:p>","DOI":"10.1155\/2012\/590463","type":"journal-article","created":{"date-parts":[[2012,12,24]],"date-time":"2012-12-24T16:00:52Z","timestamp":1356364852000},"page":"1-7","source":"Crossref","is-referenced-by-count":6,"title":["Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections"],"prefix":"10.1155","volume":"2012","author":[{"given":"Andrew J.","family":"Friedman","sequence":"first","affiliation":[{"name":"Janssen Research & Development, LLC, Titusville, New Jersey, NJ 08560, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Said M.","family":"Ali","sequence":"additional","affiliation":[{"name":"Public Health Laboratory, Ivo de Carneri, P.O. 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