Efficacy and safety of the peripheral kappa agonist fedotozine versus placebo in the treatment of functional dyspepsia.

BACKGROUND Peripheral kappa receptor agonists may provide a new therapeutic approach for the treatment of functional dyspepsia. AIMS To evaluate, in a large multicentre trial, the use of the kappa receptor agonist fedotozine to improve symptoms associated with functional dyspepsia. METHODS Two or more of the following persistent symptoms were required for inclusion: epigastric pain, early satiety, epigastric fullness or distension, nausea, vomiting, and a feeling of slow digestion. On completing a two week placebo washout, 271 patients were randomised into two groups to receive 30 mg fedotozine three times daily or placebo for six weeks under double blind conditions. RESULTS The improvement in the overall intensity of dyspeptic symptoms (main efficacy criterion) was significantly more pronounced in the fedotozine group (p = 0.002) compared with placebo, as was epigastric pain (p = 0.004) and nausea (p = 0.01); the improvement in postprandial fullness was nearly significant (p = 0.052). Inability to finish a meal and slow digestion were unaffected. The patient global score, the average of the five individual symptoms, was notably ameliorated with fedotozine (p = 0.021). The safety of fedotozine was excellent. CONCLUSIONS Fedotozine at 30 mg three times daily is safe and more effective than placebo for the relief of key symptoms associated with functional dyspepsia.