[Clinical evaluation of clarithromycin in treatment of acute dental infections. Comparative double-blind study using josamycin as the control].

In order to objectively evaluate the usefulness of clarithromycin (TE-031, A-56268), a new oral macrolide antibiotic, in the treatment of acute dental infections, a double-blind comparative clinical trail was conducted using josamycin (JM) as the control drug. TE-031 was administered at a daily dosage of 400 mg in 2 divided doses, and JM was given at a daily dosage of 1,200 mg in 3 divided doses. The administration period was, as a rule, 7 days. A total of 302 patients were administered with the test substances (TE-031 and JM), and the clinical efficacy was evaluated by investigators for 284 patients and by a committee using a score method for 273 patients. Efficacy rates as evaluated by the investigators were 77.2% (105/136) in the TE-031 group and 69.6% (103/148) in the JM group. Efficacy rates as evaluated by the committee by the score method were 86.0% (111/129) in the TE-031 group and 80.6% (116/144) in the JM group. The differences between the 2 drug groups were not statistically significant. The investigators' evaluation of the clinical efficacy in the treatment of osteitis of the jaw gave an efficacy rate of 83.0% (44/53) in the TE-031 group and 64.7% (33/51) in the JM group. The efficacy rate in the TE-031 group was statistically higher than that in the JM group. Side effects were recorded in 7 patients (4.8%) in the TE-031 group and 3 patients (2.0%) in the JM group, while abnormal laboratory test values were detected in 3 cases each in the TE-031 and JM groups. None of these differences were statistically significant. The usefulness rates ("satisfactory" plus "very satisfactory" cases) were 73.9% in the TE-031 group and 70.3% in the JM group and were thus almost the same for the 2 drug groups. On the basis of the above results, TE-031 was concluded to be a useful drug in the treatment of acute dental infections and is expected to be able to achieve almost identical clinical efficacy as JM at only one-third of the usual dosage of JM.

RCT Entities:   Population Interventions Outcomes