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

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. Eight-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.

• Authors: B Fraitag, M Homerin, P Hecketsweiler
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 39 Issue 5 Pg. 1072-7 (May 1994) ISSN: 0163-2116 [Print] United States
• PMID: 8174419 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Benzyl Compounds
• Propylamines
• fedotozine

Topics

• Adult
• Benzyl Compounds (adverse effects, therapeutic use)
• Double-Blind Method
• Dyspepsia (drug therapy)
• Female
• Humans
• Male
• Middle Aged
• Propylamines (adverse effects, therapeutic use)