{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T16:46:59Z","timestamp":1771260419208,"version":"3.50.1"},"reference-count":26,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,12,6]]},"abstract":"<jats:p>This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a new chewable, rapidly-disintegrating mebendazole (MBZ) 500 mg tablet for <jats:italic>Ascaris lumbricoides<\/jats:italic> and <jats:italic>Trichuris trichiura<\/jats:italic> infection treatment. Pediatric patients (1\u201315 years; <jats:italic>N<\/jats:italic> = 295; from Ethiopia and Rwanda) excreting <jats:italic>A. lumbricoides<\/jats:italic> and\/or <jats:italic>T. trichiura<\/jats:italic> eggs were enrolled. The study had a screening phase (3 days), a double-blind treatment phase (DBP, 19 days), and an open-label phase (OLP, 7 days). Patients received MBZ or placebo on day 1 of DBP and open-label MBZ on day 19 \u00b1 2 after stool sample collection. Cure rates (primary endpoint), defined as species-specific egg count of 0 at the end of DBP, were significantly higher in the MBZ group than placebo for <jats:italic>A. lumbricoides<\/jats:italic> (83.7% [72\/86; 95% CI: 74.2%; 90.8%] versus 11.1% [9\/81; 95% CI: 5.2%; 20.1%], <jats:italic>P<\/jats:italic> &lt; 0.001) and for <jats:italic>T. trichiura<\/jats:italic> (33.9% [42\/124; 95% CI: 25.6%; 42.9%] versus 7.6% [9\/119; 95% CI: 3.5%; 13.9%], <jats:italic>P<\/jats:italic> &lt; 0.001). Egg reduction rates (secondary endpoint) were significantly higher in the MBZ group than placebo for <jats:italic>A. lumbricoides<\/jats:italic> (97.9% [95% CI: 94.4; 99.9] versus 19.2% [95% CI: \u22125.9; 41.5]; <jats:italic>P<\/jats:italic> &lt; 0.001) and <jats:italic>T. trichiura<\/jats:italic> (59.7% [95% CI: 33.9; 78.8] versus 10.5% [95% CI: \u221216.8; 32.9]; <jats:italic>P<\/jats:italic> = 0.003). Treatment-emergent adverse events (TEAEs) in MBZ group occurred in 6.3% (9\/144) of patients during DBP and 2.5% (7\/278) during OLP. No deaths, serious TEAEs, or TEAEs leading to discontinuations were reported. A 500 mg chewable MBZ tablet was more efficacious than placebo for the treatment of <jats:italic>A. lumbricoides<\/jats:italic> and <jats:italic>T. trichiura<\/jats:italic> infections in pediatric patients, and no safety concerns were identified.<\/jats:p>","DOI":"10.4269\/ajtmh.17-0108","type":"journal-article","created":{"date-parts":[[2017,9,6]],"date-time":"2017-09-06T07:00:33Z","timestamp":1504681233000},"page":"1851-1856","source":"Crossref","is-referenced-by-count":23,"title":["Efficacy and Safety of a Single-Dose Mebendazole 500 mg Chewable, Rapidly-Disintegrating Tablet for Ascaris lumbricoides and Trichuris trichiura Infection Treatment in Pediatric Patients: A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study"],"prefix":"10.4269","volume":"97","author":[{"given":"Steven A.","family":"Silber","sequence":"first","affiliation":[{"name":"Janssen Research & Development LLC, Raritan, New Jersey;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ermias","family":"Diro","sequence":"additional","affiliation":[{"name":"University of Gondar, Gondar, Ethiopia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Netsanet","family":"Workneh","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zeleke","family":"Mekonnen","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Sciences and Pathology, College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruno","family":"Levecke","sequence":"additional","affiliation":[{"name":"Department of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Steinmann","sequence":"additional","affiliation":[{"name":"Swiss Tropical and Public Health Institute, Basel, Switzerland;"},{"name":"University of Basel, Basel, Switzerland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irenee","family":"Umulisa","sequence":"additional","affiliation":[{"name":"Rwanda Biomedical Centre, Kigali, Rwanda;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hailemaryam","family":"Alemu","sequence":"additional","affiliation":[{"name":"University of Gondar, Gondar, Ethiopia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benny","family":"Baeten","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Engelen","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Hu","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC, Raritan, New Jersey;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Friedman","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC, Raritan, New Jersey;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan","family":"Baseman","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC, Raritan, New Jersey;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Mrus","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC, Raritan, New Jersey;"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2795","reference":[{"key":"b1","author":"WHO","year":"2006"},{"key":"b2","series-title":"Lancet","first-page":"1603","article-title":"Global, 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