{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:11:24Z","timestamp":1777417884532,"version":"3.51.4"},"reference-count":18,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2002,9,1]],"date-time":"2002-09-01T00:00:00Z","timestamp":1030838400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2002,9]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Historically, single-patient trials (SPTs) have been specifically designed for each patient, requiring significant time and effort for execution. There has been no previous attempt to standardize an SPT for routine commercial availability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>OBJECTIVE:<\/jats:title>\n                    <jats:p>To validate the use of an SPT method to discriminate effectiveness and adverse events while comparing drugs\/doses in patients with allergic rhinitis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DESIGN:<\/jats:title>\n                    <jats:p>Double-blind, randomized, 4 paired\u2014period, multiple-crossover SPT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>SETTING:<\/jats:title>\n                    <jats:p>Academic and commercial investigative sites.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS:<\/jats:title>\n                    <jats:p>Thirty-six patients with allergic rhinitis were evaluated for the most appropriate treatment; 6 of these participated in 2 different SPTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>INTERVENTIONS:<\/jats:title>\n                    <jats:p>Treatment of symptoms of allergic rhinitis by comparing either loratadine with chlorpheniramine maleate or loratadine with placebo in a series of SPTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>MEASUREMENTS:<\/jats:title>\n                    <jats:p>Effectiveness endpoints were selected from a modern, Food and Drug Administration (FDA)-approved new drug application. Expected adverse events were directly solicited; unsolicited events were also recorded. Total signs and symptoms cumulatively included sneezing, runny nose, itchy nose, teary eyes, and itchy eyes. Quality of life was measured by the most bothersome symptom and the patient's global evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>Of 42 initiated SPTs, 40 (95%) provided complete data and 1 (2%) provided partial data, resulting in 41 (98%) evaluable tests. Thirty-one evaluable SPTs compared loratadine 10 mg\/d with chlorpheniramine maleate 12 mg twice daily, and 10 SPTs compared loratadine 10 mg\/d with placebo. Four of 31 SPTs (13%) showed significant superiority for loratadine over chlorpheniramine maleate and 5 of 31 (16%) for chlorpheniramine maleate over loratadine. Twenty-two of 31 (71%) showed parity performance between loratadine and chlorpheniramine maleate. Loratadine was significantly superior to placebo in 3 of 10 trials (30%), consistent with rates found in 3 pivotal group trials used for FDA approval (24%, 17%, and 0%). Sleepiness could be discriminated for loratadine versus placebo and for chlorpheniramine maleate versus loratadine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>The allergic rhinitis SPT proved to be acceptable to patients, feasible to administer, and reproducible. It can statistically discriminate effectiveness and adverse events, serving as a useful, prognostic tool in community practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1345\/aph.1c031","type":"journal-article","created":{"date-parts":[[2003,6,4]],"date-time":"2003-06-04T16:23:45Z","timestamp":1054743825000},"page":"1366-1374","source":"Crossref","is-referenced-by-count":4,"title":["Single-Patient Drug Trial Methodology for Allergic Rhinitis"],"prefix":"10.1177","volume":"36","author":[{"given":"Donald P","family":"Reitberg","sequence":"first","affiliation":[{"name":"Donald P Reitberg PharmD, President, Scientific Affairs, Opt-e-scrip, Inc., Morristown, NJ"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eve Del","family":"Rio","sequence":"additional","affiliation":[{"name":"Eve Del Rio PhD, Vice President, Clinical Research & Operations, Opt-e-scrip, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sidney L","family":"Weiss","sequence":"additional","affiliation":[{"name":"Sidney L Weiss MS, Vice President, Biostatistics & Information Technology, Opt-e-scrip, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerbert","family":"Rebell","sequence":"additional","affiliation":[{"name":"Gerbert Rebell MS, Director of Mycology, Mount Sinai Medical Center, Miami Beach, FL"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nardo","family":"Zaias","sequence":"additional","affiliation":[{"name":"Nardo Zaias MD, Director, Department of Dermatology, Mount Sinai Medical Center"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2002,9,1]]},"reference":[{"key":"bibr-bibr1-aph.1C031","first-page":"277","volume-title":"Guide to clinical trials","author":"Spilker B","year":"1996"},{"key":"bibr-bibr2-aph.1C031","first-page":"313","volume-title":"Guide to clinical trials","author":"Spilker B","year":"1996"},{"key":"bibr-bibr3-aph.1C031","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.290.6484.1795"},{"key":"bibr-bibr4-aph.1C031","first-page":"67","volume":"8","author":"Levy S","year":"2000","journal-title":"Drug Topics"},{"key":"bibr-bibr5-aph.1C031","volume-title":"Summary basis of approval for Claritin: NDA 19\u2013658; Studies C84\u2013111 and I84\u2013317","year":"1995"},{"key":"bibr-bibr6-aph.1C031","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198604033141406"},{"key":"bibr-bibr7-aph.1C031","unstructured":"Medwatch. The FDA medical products reporting program. FDA form 3500 [cited 2001 Sept 27]. Available from: URL: http:\/\/www.fda.gov\/medwatch\/safety\/3500.pdf."},{"key":"bibr-bibr8-aph.1C031","unstructured":"American hospital formulary service drug information. Bethesda, MD: American Society of Health-System Pharmacists, 2002:18\u201321,34\u201340."},{"key":"bibr-bibr9-aph.1C031","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1993.03510220064035"},{"key":"bibr-bibr10-aph.1C031","first-page":"211","volume-title":"Statistical methods","author":"Snedecor GW","year":"1967","edition":"6"},{"key":"bibr-bibr11-aph.1C031","unstructured":"Reitberg DP, inventor; Opt-e-scrip Incorporated, assignee. Method and kit for treating illnesses. US Patent 6,242,463. June 5, 2001. Additional patents pending."},{"key":"bibr-bibr12-aph.1C031","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(96)00429-5"},{"key":"bibr-bibr13-aph.1C031","first-page":"32","volume-title":"Hierarchical linear models","author":"Bryk AS","year":"1992"},{"key":"bibr-bibr14-aph.1C031","doi-asserted-by":"publisher","DOI":"10.1016\/0091-6749(88)90082-6"},{"key":"bibr-bibr15-aph.1C031","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-112-4-293"},{"key":"bibr-bibr16-aph.1C031","doi-asserted-by":"publisher","DOI":"10.1007\/BF00606669"},{"key":"bibr-bibr17-aph.1C031","unstructured":"Hall SS. The Claritin effect. Why drugs cost so much: A case study. The New York \u00d7 Magazine 2001;Mar 11:6."},{"key":"bibr-bibr18-aph.1C031","unstructured":"Wortman M. Medicine gets personal. MIT technology review [serial online]. 2001 Jan-Feb [cited 2001 Sept 14]: [11 screens]. 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