Optimal dose of N-22 (Mofezolac), a new non-steroidal anti-inflammatory agent, was evaluated in a double-blind comparative study on post-exodontic pain, at 3 single dosing levels of 100 mg, 150 mg and 200 mg, respectively. The results are summarized as follows.
1) A total of 197 cases subjected for analysis are broken down into a group of 68 cases with a 100mg dose, that of 64 eases with a 150mg dose and that of 65 cases with a 200mg dose, respectively. No significant deviation in clinical background factors of all cases was recognized.
2) A total of 189 cases (67 cases-100mg, 60-150mg arid 62-200mg) were subjected for analysis of its efficacy. Analysis by U-test proved both 150 mg and 200mg groups to be significantly superior (P<0.05 and PK<0.01) to 100 mg group. The improvement rates (“Improved or more”) were 61.2%(41/67) with 100mg, 73. 3%(44/60) with 150mg and 78.8%(47/62) with 200mg, respectively.
3) Side effects were observed in 3 cases; an iching sensation in one of 100 mg group and drowsiness/headache in two of 200mg group, all of which was transient, with no clinical sign of being serious.
4) A total of 189 cases were subjected for analysis of its clinical usefulness (67 cases-100mg, 60-150mg and 62-200mg). U-test proved both 150mg and 200mg to be significantly superior (P<-0.05 and P<0.001) to 100mg.
On the basis of the foregoing results, the optimal dose at clinical sign of post-exoclontic pain is estimated to be a single dose regimen of 150mg.
