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

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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.

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Authors and Affiliations

  1. the Hôpital Charles Nicolle, Rouen, France

    B. Fraitag MD, M. Homerin MD & P. Hecketsweiler MD

  2. Institut de Recherche Jouveinal, 3-9 rue de la Loge, F-94265, Fresnes Cedex, France

    B. Fraitag MD, M. Homerin MD & P. Hecketsweiler MD

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  1. B. Fraitag MD
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  2. M. Homerin MD
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  3. P. Hecketsweiler MD
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Fraitag, B., Homerin, M. & Hecketsweiler, P. Double-blind dose-response multicenter comparison of fedotozine and placebo in treatment of nonulcer dyspepsia. Digest Dis Sci 39, 1072–1077 (1994). https://doi.org/10.1007/BF02087560

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  • DOI: https://doi.org/10.1007/BF02087560

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