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

Abstract

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.

• Authors: M Dapoigny, J L Abitbol, B Fraitag
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 40 Issue 10 Pg. 2244-9 (Oct 1995) ISSN: 0163-2116 [Print] United States
• PMID: 7587797 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

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

Topics

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