Clinical evaluation of AD-1590 in pain after tonsillectomy

A double-blind comparative study with indomethacin

Abstract

The utility of AD-1590 (A group) in pain after tonsillectomy was investigated with a multicenter collaborative double-blind design using indomethacin (I group) as a control drug. 1) A total number of 140 patients (71 A group and 69 I group) were treated. Out of 140, 133 (67 A group; 66 I group) were included in all evaluations and 7 (4 A group,; 3 I group) were partially evaluated. No significant bias was found in patient population or in characteristics between the two groups. 2) There was no significant difference in the analgesic effect of the first dose between the two groups. The improvement rate covering “≥ moderately improved” was 55.9% in the A group and 50.7% in the I group. 3) No significant difference was found in overall improvement between the two groups.“Moderately improved” and higher ratings accounted for 68.7% in the A group and 68.2% in the I group. 4) There was no significant difference in the incidence of side effects between the two groups. The incidence of side effects was 5.6% (4 out of 71) in the A group and 1.4% (1 out of 69) in the I group. 5) In the utility evaluation, there was no significant difference between the two groups. The utility rate covering “≥ useful” was 71.6% in the A group and 68.7% in the I group.