M. Dapoigny et al., EFFICACY OF PERIPHERAL KAPPA-AGONIST FEDOTOZINE VERSUS PLACEBO IN TREATMENT OF IRRITABLE-BOWEL-SYNDROME - A MULTICENTER DOSE-RESPONSE STUDY, Digestive diseases and sciences, 40(10), 1995, pp. 2244-2249
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 fedo
tozine 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 disorder
s 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 = 0.0
09). Clinical and laboratory safety was very good. Fedotozine 30 mg th
ree times a day therefore appears to be effective and safe in the trea
tment of the abdominal pain and bloating associated with IBS.