Background: 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. We aimed to test the efficacy and safety of this drug in FD. Methods: Two similar placebo-controlled clinical trials were conducted (International and North America). Males and females, 18 to 65 years, with a diagnosis of FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. All were negative for H. pylori and, if present, heartburn could not exceed one episode per week. Following screening, patients were randomized to itopride 100 mg three times daily or identical placebo. The co-primary endpoints were: 1) Global Patient Assessment of efficacy (GPA); 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. Results: The GPA responder rates at week 8 on Itopride versus placebo were similar in both trials (50.2% vs. 49.8% and 41.8 vs. 39.1%; respectively; P=NS). A significant benefit of itopride over placebo was observed for the LDQ responders in the International (62% vs. 53%, P=0.04) but not the North American trial (47% vs. 45%). The safety and tolerability profile were comparable to placebo, with the exception of prolactin elevations, which occurred more frequently on itopride (18/579) than placebo (1/591). Conclusion: In this population with FD, itopride did not show a difference in symptom response from placebo.
- clinical trial
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