Digestive Diseases and Sciences

, Volume 39, Issue 5, pp 1072–1077

Double-blind dose-response multicenter comparison of fedotozine and placebo in treatment of nonulcer dyspepsia

  • B. Fraitag
  • M. Homerin
  • P. Hecketsweiler
Article

DOI: 10.1007/BF02087560

Cite this article as:
Fraitag, B., Homerin, M. & Hecketsweiler, P. Digest Dis Sci (1994) 39: 1072. doi:10.1007/BF02087560

Abstract

The efficacy and safety of the peripheral kappa-receptor agonist fedotozine was investigated in a double-blind, placebo-controlled, dose-ranging study involving 146 patients with nonulcer dyspepsia (NUD). After a two-week washout, patients were assigned to one of four groups to receive either placebo or fedotozine three times a day at doses of 10, 30, or 70 mg for six weeks. Analysis of mean symptom intensity scores showed that the 30-and 70-mg doses of fedotozine were superior to placebo in relieving postprandial fullness, bloating, abdominal pain, and nausea. Eructation and early satiety were marginally affected. The 30-mg dose was significantly more effective than placebo in reducing the total symptom score. Eighty-two mostly minor adverse effects were recorded, but no significant differences in distribution emerged between placebo and treatment groups. The number of withdrawals declined significantly as a function of increasing dose. These results indicate that 30 mg three times a day is the minimal effective dose of fedotozine in the treatment of NUD symptoms and that this treatment is safe.

Key words

fedotozine nonulcer dyspepsia 

Copyright information

© Plenum Publishing Corporation 1994

Authors and Affiliations

  • B. Fraitag
    • 2
    • 1
  • M. Homerin
    • 2
    • 1
  • P. Hecketsweiler
    • 2
    • 1
  1. 1.the Hôpital Charles NicolleRouenFrance
  2. 2.Institut de Recherche JouveinalFresnes CedexFrance