Dyspepsia

Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials

N J Talley¹, J Tack², T Ptak³, R Gupta⁴, M Giguère⁵

¹ Mayo Clinic College of Medicine, Department of Internal Medicine, Jacksonville, Florida, USA
² Department of Gastroenterology, University Hospital, Leuven, Belgium
³ Toronto Digestive Disease Associates, Toronto, Canada
⁴ Hopewell Valley Medical Group, Trenton, New Jersey, USA
⁵ Axcan Pharma Inc., USA

Professor N J Talley, Mayo Clinic College of Medicine, Department of Internal Medicine, 4500 San Pablo Road, Jacksonville, FL 32082, USA; talley.nicholas{at}mayo.edu

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. The aim of this study was 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, 18–65 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 Helicobacter pylori 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.

Results: 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 = NS). A significant benefit of itopride over placebo was observed for the LDQ responders in the International (62% vs 52.7%, p = 0.04) 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).

Conclusion: In this population with FD, itopride did not show a difference in symptom response from placebo.

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Relevant Article

Pitfalls in designing trials of functional dyspepsia: the ascent and demise of itopride

Sander J O Veldhuyzen Van Zanten
Gut 2008 57: 723-724. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

• Veldhuyzen Van Zanten, S. J O (2008). Pitfalls in designing trials of functional dyspepsia: the ascent and demise of itopride. Gut 57: 723-724 [Full Text]