{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T03:25:56Z","timestamp":1792034756010,"version":"4.4.0"},"reference-count":26,"publisher":"BMJ","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Gut"],"published-print":{"date-parts":[[2008,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Functional dyspepsia (FD) is a common disorder but there is currently little efficacious drug therapy. Itopride, a prokinetic approved in several countries, showed promising efficacy in FD in a phase IIb trial. The aim of this study was to test the efficacy and safety of this drug in FD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      Two similar placebo-controlled clinical trials were conducted (International and North America). Males and females, 18\u201365 years old, with a diagnosis of FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. All were negative for\n                      <jats:italic>Helicobacter pylori<\/jats:italic>\n                      and, if present, heartburn could not exceed one episode per week. Following screening, patients were randomised to itopride 100 mg three times daily or identical placebo. The co-primary end points were: (1) global patient assessment (GPA) of efficacy; and (2) Leeds Dyspepsia Questionnaire (LDQ). Symptoms were evaluated at weeks 2, 4 and 8. Secondary measures of efficacy included Nepean Dyspepsia Index (NDI) quality of life.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The GPA responder rates at week 8 on itopride versus placebo were similar in both trials (45.2% vs 45.6% and 37.8 vs 35.4%, respectively; p\u200a=\u200aNS). A significant benefit of itopride over placebo was observed for the LDQ responders in the International (62% vs 52.7%, p\u200a=\u200a0.04) but not the North American trial (46.9% vs 44.8%). The safety and tolerability profile were comparable with placebo, with the exception of prolactin elevations, which occurred more frequently on itopride (18\/579) than placebo (1\/591).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>In this population with FD, itopride did not show a difference in symptom response from placebo.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/gut.2007.132449","type":"journal-article","created":{"date-parts":[[2007,10,26]],"date-time":"2007-10-26T18:52:03Z","timestamp":1193424723000},"page":"740-746","source":"Crossref","is-referenced-by-count":156,"title":["Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials"],"prefix":"10.1136","volume":"57","author":[{"given":"N J","family":"Talley","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J","family":"Tack","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T","family":"Ptak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R","family":"Gupta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Gigu\u00e8re","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2007,10,26]]},"reference":[{"key":"2025112109181560000_57.6.740.1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.059"},{"key":"2025112109181560000_57.6.740.2","doi-asserted-by":"publisher","DOI":"10.1007\/s11938-007-0068-1"},{"key":"2025112109181560000_57.6.740.3","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2004.01897.x"},{"key":"2025112109181560000_57.6.740.4","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.09.020"},{"key":"2025112109181560000_57.6.740.5","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2004.08.026"},{"key":"2025112109181560000_57.6.740.6","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1746.2006.04493.x"},{"key":"2025112109181560000_57.6.740.7","doi-asserted-by":"crossref","first-page":"689","DOI":"10.1016\/S0002-9270(00)02314-5","article-title":"Efficacy of cisapride and domperidone in functional (nonulcer) dyspepsia: a meta-analysis.","volume":"96","author":"Veldhuyzen van Zanten","year":"2001","journal-title":"Am J Gastroenterol"},{"key":"2025112109181560000_57.6.740.8","first-page":"643","article-title":"Tegaserod significantly improves moderate\u00e2\u0080\u0093severe dysmotility symptoms in patients with functional dyspepsia.","volume":"132","author":"Vakil","year":"2007","journal-title":"Gastroenterology"},{"key":"2025112109181560000_57.6.740.9","doi-asserted-by":"crossref","unstructured":"Moayyedi P Soo S Deeks J . 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