{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T14:06:58Z","timestamp":1776694018243,"version":"3.51.2"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2019,7,5]],"date-time":"2019-07-05T00:00:00Z","timestamp":1562284800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This multicenter, double\u2010blind, placebo\u2010controlled, randomized study was designed to evaluate the efficacy and safety of pseudoephedrine hydrochloride 30\u2010mg tablets in children aged 6 to 11\u00a0years for the temporary relief of nasal congestion due to the common cold. The primary efficacy end point was the weighted sum of the change from baseline in instantaneous nasal congestion severity score over the period from 1 to 8 hours following the first dose of study drug on day 1. Safety assessments included adverse events, sleepiness ratings, and vital signs. Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8\u00a0hours after dosing on day\u00a01 (least squares mean difference between treatment groups was 1.2;\u00a0<jats:italic>P<\/jats:italic> = .029). Overall, secondary end points associated with nasal congestion were supportive on day 1, whereas secondary end points on day 2 were only numerically favorable. Somnolence was reported in a greater percentage of children on pseudoephedrine compared to placebo (71.9% vs 63.9%), while similar percentages of children in the same respective groups reported insomnia (34.4% and 38.9%) and nervousness (20.0% and 23.6%).Pseudoephedrine provides temporary relief of nasal congestion associated with the common cold in children 6 to &lt;12 years of age at the current over\u2010the\u2010counter monograph dose. Multiple dosing of pseudoephedrine for up to 7\u00a0days, when given as needed for symptom relief, was generally safe in this population of children with the common cold.<\/jats:p>","DOI":"10.1002\/jcph.1472","type":"journal-article","created":{"date-parts":[[2019,7,5]],"date-time":"2019-07-05T10:58:33Z","timestamp":1562324313000},"page":"1573-1583","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["A Multicenter, Randomized, Placebo\u2010Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold"],"prefix":"10.1002","volume":"59","author":[{"given":"Cathy K.","family":"Gelotte","sequence":"first","affiliation":[{"name":"Johnson &amp; Johnson Consumer Inc  Fort Washington PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helmut H.","family":"Albrecht","sequence":"additional","affiliation":[{"name":"Department of Cellular Biology and Pharmacology Herbert Wertheim College of Medicine, Florida International University  Miami FL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Hynson","sequence":"additional","affiliation":[{"name":"Concentrics Research  Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valerie","family":"Gallagher","sequence":"additional","affiliation":[{"name":"Perrigo Company  Allegan MI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,7,5]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1978.tb04588.x"},{"issue":"6","key":"e_1_2_10_3_1","first-page":"143S","article-title":"The pharmacology of alpha\u2010adrenergic decongestants","volume":"13","author":"Johnson DA","year":"1993","journal-title":"Pharmacotherapy"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-198121060-00003"},{"key":"e_1_2_10_5_1","first-page":"215","volume-title":"Goodman & Gilman's The Pharmacologic Basis of Therapeutics","author":"Hoffman BB","year":"2001"},{"key":"e_1_2_10_6_1","first-page":"157","article-title":"Symptomatic treatment of common cold in children with a new combination of naproxen sodium plus pseudoephedrine hydrochloride: a comparative trial against pseudoephedrine syrup","volume":"37","author":"Martinez Gallardo F","year":"1994","journal-title":"Proc West Pharmacol Soc"},{"issue":"4","key":"e_1_2_10_7_1","first-page":"475","article-title":"Therapeutic approaches to the common cold in children","volume":"6","author":"Weippl G.","year":"1984","journal-title":"Clin Ther"},{"key":"e_1_2_10_8_1","unstructured":"FDA Advisory Meeting.Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee 2007.https:\/\/wayback.archive-it.org\/7993\/20170404050526\/https:\/\/www.fda.gov\/ohrms\/dockets\/ac\/07\/minutes\/2007-4323m1-Final.pdf. Accessed November 4 2018."},{"issue":"1","key":"e_1_2_10_9_1","article-title":"Evaluation of the performance of pediatric OTC monograph dosing guidance for pseudoephedrine via population pharmacokinetic modeling and simulation","volume":"89","author":"Gastonguay MR","year":"2011","journal-title":"Clin Pharmacol Therap"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1208\/ps020103"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0378-4347(00)81077-4"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(96)70157-9"},{"key":"e_1_2_10_13_1","unstructured":"Halstead P Arbuckly R Marshall C et\u00a0al.Development and content validity testing of patient\u2010reported outcome items for children to self\u2010assess symptoms of the common cold. In press."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/27.3.541"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40271-013-0022-3"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-4-79"},{"issue":"3","key":"e_1_2_10_17_1","first-page":"265","article-title":"The Wisconsin Upper Respiratory Symptom Survey (WURSS): a new research instrument for assessing the common cold","volume":"51","author":"Barrett B","year":"2002","journal-title":"J Fam Pract"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2273.1999.00208.x"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1681.2004.04013.x"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.2500\/ajr.2007.21.3041"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1177\/194589240501900105"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.1472","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1472","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcph.1472","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1472","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T20:05:24Z","timestamp":1694203524000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.1472"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7,5]]},"references-count":20,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["10.1002\/jcph.1472"],"URL":"https:\/\/doi.org\/10.1002\/jcph.1472","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7,5]]},"assertion":[{"value":"2019-02-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-06-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-07-05","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}