The aim of this study was to assess the efficacy and tolerance of
propinox administered i.v., and establish a dose-response relation according to three dose levels (10, 20 and 30 mg), vs. placebo in patients with moderate to severe acute biliary
pain. Three hundred and fifty patients were included: 85 received placebo treatment, 81 were treated with
propinox 10 mg, 91 with
propinox 20 mg and 93 received
propinox 30 mg. Spontaneous
pain intensity was assessed according to a visual analog and a verbal scale before treatment and 20, 60 and 120 min after. All treatments induced significant and progressive
pain reduction at all controls, but patients treated with 20 and 30 mg of
propinox showed significantly lower
pain intensity after 120 min compared to the placebo group. The last control revealed that 28% of patients receiving placebo had no
pain while 60% of patients treated with
propinox 30 mg reported absence of
pain with a statistically significant difference (p < 0.001). All treatments were very well tolerated and there were no dropouts due to adverse events.
Mouth dryness was the adverse effect occurring with a significantly higher frequency than that observed with placebo although it was only seen in patients treated with 20 mg and 30 mg active doses. The results of this study showed that
propinox was an effective
drug in the treatment of moderate to severe
colic pain of biliary origin. Concerning efficacy and side effects, a clear dose-response relation was observed; the 20 mg and 30 mg doses being significantly superior to placebo.