Efficacy of peripheral kappa agonist fedotozine versus placebo in treatment of irritable bowel syndrome. A multicenter dose-response study

Dig Dis Sci. 1995 Oct;40(10):2244-9. doi: 10.1007/BF02209014.


The efficacy and safety of the peripheral kappa agonist fedotozine was evaluated in a double-blind, multicenter study involving 238 patients with the irritable bowel syndrome. 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 3.5, 15, or 30 mg for six weeks. Patient assessment of mean symptom intensity indicated that the 30-mg dose of fedotozine was superior to placebo in relieving maximal daily abdominal pain (P = 0.01), mean daily pain (P = 0.007), and abdominal bloating (P = 0.02). Changes in bowel function and defecation disorders could not be evaluated reliably. According to the investigators, the highest dose of fedotozine markedly reduced overall disease severity (P = 0.003) and the pain component of the symptomatic profile (P = 0.009). Clinical and laboratory safety was very good. Fedotozine 30 mg three times a day therefore appears to be effective and safe in the treatment of the abdominal pain and bloating associated with IBS.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Analysis of Variance
  • Belgium
  • Benzyl Compounds / administration & dosage*
  • Benzyl Compounds / adverse effects
  • Colonic Diseases, Functional / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • France
  • Humans
  • Placebos
  • Propylamines / administration & dosage*
  • Propylamines / adverse effects
  • Receptors, Opioid, kappa / agonists*
  • Remission Induction
  • Tunisia


  • Benzyl Compounds
  • Placebos
  • Propylamines
  • Receptors, Opioid, kappa
  • fedotozine