| 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
(Affiliation: Surgical Department, NAL, Trollhättan, Sweden, CHU Clermont Ferrand, Dieu, France. bengt.hallerback at vgregion.se)
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| Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 16
Issue 5
Pg. 959-67
(May 2002)
ISSN: 0269-2813 England |
| PMID | 11966505
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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| 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
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