A double-blind, randomized, placebo-controlled trial of itopride (100 and 200 mg three times daily) on gastric motor and sensory function in healthy volunteers.

Abstract

Itopride, a dopamine D2 antagonist and acetylcholinesterase inhibitor, significantly improved symptoms in patients with functional dyspepsia in one phase II randomized trial. However, the mechanisms by which itopride may improve symptoms are unknown. We aimed to compare the effects of two doses of itopride and placebo on gastric volumes, gastric emptying, small bowel transit and satiation in female and male healthy volunteers. Randomized, double-blind, placebo-controlled study evaluated gastric function before and after 7 days of itopride 100 mg (n = 16) or 200 mg (n = 15) or placebo (n = 15) t.i.d. Validated methods were used to study gastric accommodation (single photon emission computed tomography), gastric emptying and orocecal transit and satiation postnutrient challenge. The three arms were comparable with regard to age, gender and body mass index. There were no statistically significant effects of itopride on gastric emptying, orocecal transit, fasting gastric volume, maximum tolerated volume or aggregate symptom score with nutrient drink challenge. Postprandial (PP) change in gastric volume differed in the three groups (P = 0.019): 625[+/-28 (SEM)], 555(+/-26) and 512(+/-33) in placebo, itopride 100 and 200 mg groups, respectively. In healthy subjects, itopride reduced total PP gastric volume without accelerating gastric emptying or significantly altering gastric motor and sensory function in healthy individuals.

• Authors: R S Choung, N J Talley, J Peterson, M Camilleri, D Burton, W S Harmsen, A R Zinsmeister
• Journal: Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society (Neurogastroenterol Motil) Vol. 19 Issue 3 Pg. 180-7 (Mar 2007) ISSN: 1350-1925 [Print] England
• PMID: 17300287 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Benzamides
• Benzyl Compounds
• Dopamine Antagonists
• itopride

Topics

• Benzamides (pharmacology)
• Benzyl Compounds (pharmacology)
• Dopamine Antagonists (pharmacology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Gastric Emptying (drug effects)
• Gastrointestinal Motility (drug effects)
• Humans
• Male
• Satiation (drug effects)
• Stomach (drug effects)
• Tomography, Emission-Computed, Single-Photon