{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T16:39:14Z","timestamp":1765039154518,"version":"3.46.0"},"reference-count":20,"publisher":"BMJ","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Gut"],"accepted":{"date-parts":[[2011,2,2]]},"published-print":{"date-parts":[[2011,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the efficacy and tolerability of add-on treatment with lesogaberan (AZD3355), a novel reflux inhibitor, in patients with persistent gastro-oesophageal reflux disease (GORD) symptoms despite proton pump inhibitor (PPI) therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A double-blind, placebo-controlled, randomised, parallel-group, multicentre phase IIA study was carried out in outpatient clinics. The study group comprised 244 adult patients with persistent GORD symptoms (heartburn and\/or regurgitation) of at least mild intensity and for 3\u2005days of 7 days before enrolment, despite \u22656\u2005weeks of continuous PPI therapy. Patients received either lesogaberan (65\u2005mg twice daily) or placebo in addition to PPI therapy for a period of 4\u2005weeks. Symptom intensity, based on the Reflux Disease Questionnaire, was recorded twice daily. Treatment response (defined as at most one 24\u2005h period with heartburn or regurgitation of not more than mild intensity during the last 7\u2005days of treatment). Time to response, proportion of symptom-free days and measures of tolerability were also analysed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 232 (114 lesogaberan- and 118 placebo-treated patients) of the 244 randomised patients were analysed for efficacy. Treatment with lesogaberan, compared with placebo, resulted in a significantly larger proportion of responders to treatment (16% vs 8% of patients; p=0.026) and cumulative proportion of responders over time (log-rank p=0.0195). Lesogaberan was well tolerated: adverse events of mostly mild to moderate intensity were reported in 45% of patients on lesogaberan and in 37% on placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Lesogaberan add-on therapy to PPIs significantly improved heartburn and regurgitation symptoms; however, the proportion of responders was small.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial number<\/jats:title>\n                    <jats:p>NCT00394472.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/gut.2010.235630","type":"journal-article","created":{"date-parts":[[2011,3,15]],"date-time":"2011-03-15T16:29:25Z","timestamp":1300206565000},"page":"1182-1188","source":"Crossref","is-referenced-by-count":67,"title":["A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial"],"prefix":"10.1136","volume":"60","clinical-trial-number":[{"clinical-trial-number":"nct00394472","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Guy E","family":"Boeckxstaens","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanneke","family":"Beaumont","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan G","family":"Hatlebakk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debra G","family":"Silberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"Bj\u00f6rck","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Karlsson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans","family":"Denison","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2011,3,14]]},"reference":[{"key":"2025120520120783000_60.9.1182.1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2004.051821"},{"key":"2025120520120783000_60.9.1182.2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.08.044"},{"key":"2025120520120783000_60.9.1182.3","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200767110-00001"},{"key":"2025120520120783000_60.9.1182.4","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2982.2008.01096.x"},{"key":"2025120520120783000_60.9.1182.5","first-page":"109","article-title":"Inhibitors of transient lower esophageal sphincter relaxations (\u201creflux inhibitors\u201d) in the future treatment of GERD","volume":"1","author":"Lehmann","year":"2006","journal-title":"Gastroenterol Hepatol Annu Rev"},{"key":"2025120520120783000_60.9.1182.6","doi-asserted-by":"publisher","DOI":"10.1136\/gut.50.1.19"},{"key":"2025120520120783000_60.9.1182.7","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2002.01250.x"},{"key":"2025120520120783000_60.9.1182.8","doi-asserted-by":"publisher","DOI":"10.1136\/gut.52.10.1397"},{"key":"2025120520120783000_60.9.1182.9","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2009.247"},{"key":"2025120520120783000_60.9.1182.10","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2002.01325.x"},{"key":"2025120520120783000_60.9.1182.11","unstructured":"EMC. 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