The aim of this double-blind study was to assess the efficacy and tolerability of
propinox administered i.v. and to establish a dose-response relationship according to three dose levels (10 mg, 20 mg and 30 mg), vs. placebo in patients with moderate-to-severe acute intestinal
colic pain. Four hundred patients (100 per treatment group) were included and allocated to the following treatment groups:
propinox 10 mg, 20 mg, 30 mg and placebo. All treatments induced significant and progressive
pain reduction as from the 20 min evaluation of 20.3% in the placebo group, 45% in the group treated with
propinox 10 mg; 52% in the group receiving
propinox 20 mg and 56% in the
propinox 30 mg group. Statistical comparison showed differences between placebo and the three active doses as well as between
propinox 10 mg and the 20 mg and 30 mg doses. The 20 min evaluation revealed that 40% of patients receiving placebo had to be excluded from the study due to lack of efficacy; the percentage of which was significantly higher compared with those observed with the three doses of
propinox ranging between 10% and 13%. The 120 min evaluation revealed that 47.7% of patients treated with
propinox 10 mg were free from
pain vs. 68.8% and 73.5% of those receiving 20 mg and 30 mg, respectively. These percentages were considerably higher than the 15% found with placebo. Statistical analysis revealed significant differences between the 10 mg vs. the 20 mg and 30 mg groups with not differences between the latter doses. No differences in blood pressure or heart rate were found among treatments. The incidence of
mouth dryness was significantly more frequent with the 20 mg and 30 mg doses of
propinox than with the placebo or the 10 mg dose.