Efficacy of peripheral kappa agonist fedotozine versus placebo in treatment of irritable bowel syndrome. A multicenter dose-response study.
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.
Dapoigny
M
M
Department of Hepato-Gastroenterology, Hôtel Dieu, Clermont-Ferrand, France.
Abitbol
J L
JL
Fraitag
B
B
D000328:Adult; D000704:Analysis of Variance; D001530:Belgium; D001593:Benzyl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D003109:Colonic Diseases, Functional / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005602:France; D006801:Humans; D010919:Placebos; D011437:Propylamines / Q000008:administration & dosage* / Q000009:adverse effects; D017473:Receptors, Opioid, kappa / Q000819:agonists*; D012074:Remission Induction; D014416:Tunisia
D001593:Benzyl Compounds; D010919:Placebos; D011437:Propylamines; D017473:Receptors, Opioid, kappa; C067749:fedotozine