Dose finding study of mosapride in functional dyspepsia: a placebo-controlled, randomized study.

Abstract

BACKGROUND:

Prokinetic agents have shown variable efficacy in the treatment of functional dyspepsia. Mosapride is a new prokinetic 5-hydroxytryptamine-4 agonistic agent.

AIM:

To evaluate the efficacy of three dosage regimens of mosapride compared with placebo in the treatment of functional dyspepsia.

METHODS:

Patients were randomly allocated to treatment with placebo or mosapride (5 mg b.d., 10 mg b.d. or 7.5 mg t.d.s.) in a double-blind, prospective, multicentre, multinational study. The change in symptom severity score from an untreated baseline week to the sixth week of treatment was used to compare treatment efficacy.

RESULTS:

There were 141, 140, 143 and 142 patients valid for evaluation in the intention-to-treat population in the placebo, mosapride 5 mg b.d., mosapride 10 mg b.d. and mosapride 7.5 mg t.d.s. groups, respectively. The mean changes in the overall dyspeptic symptom score were - 0.90, - 0.94, - 0.88 and - 0.89, respectively, and the proportions of patients feeling better at the end of the treatment period were 60%, 59%, 59% and 61%, respectively. No statistically significant difference was seen.

CONCLUSIONS:

Treatment of functional dyspepsia with mosapride was not superior to placebo. The result raises the question of whether treatment with prokinetic agents is appropriate for functional dyspepsia.

• Authors: B I Hallerbäck, G Bommelaer, E Bredberg, M Campbell, M Hellblom, K Lauritsen, M Wienbeck, L-L Holmgren
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 16 Issue 5 Pg. 959-67 (May 2002) ISSN: 0269-2813 [Print] England
• PMID: 11966505 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Benzamides
• Gastrointestinal Agents
• Morpholines
• mosapride

Topics

• Adult
• Benzamides (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Dyspepsia (drug therapy)
• Female
• Gastrointestinal Agents (administration & dosage, adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Morpholines (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome