Abstract
We compared TS-110 with a control drug, diclofenac, by means of the doubleblind method for objective assessment of the clinical usefulness of TS-110 against osteoarthritis.
Study drugs were administered to a total of 225 subjects, and 94 and 95 subjects in TS-110 and diclofenac sodium groups, respectively, were included in efficacy analysis, 107 and 108 subjects, respectively, in safety analysis, and 98 and 100 subjects, respectively, in analysis of usefulness. The following results were obtained:
1. As to the final global improvement rating, the percentage of subjects with “improvement” or better grades was 72.3% (68/94 subjects) in the TS-110 group and 65.3% (62/95 subjects) in diclofenac sodium group and no significant differences were observed. The relative 90% confidence interval in Group T was-4.0 to 18.1% in comparison to the improvement rate in Group D, and was in the range in which equivalence could be verified.
2. The incidences of adverse reactions were 25.2% (27/107 subjects) and 25.9% (28/108 subjects) in TS-110 and diclofenac sodium groups, respectively. Gastrointestinal symptoms such as abdominal pain and discomfort in the abdominal region were common in both groups, but no serious adverse reactions were observed.
3. Concerning the overall safety rating, the percentage of subjects in whom the drug was “safe” was 74.8% (80/107 subjects) in the TS-110 group and 73.1% (79/108 subjects) in the diclofenac sodium group, and no significant differences were observed.
4. As to the utility rating, the percentage of subjects in whom the drug was “useful” or better was 59.2% (58/98 subjects) in the TS-110 group and 53.0% (53/100 subjects) in diclofenac sodium group, and no significant differences were noted.
Thus, TS-110 was judged to be a clinically useful drug for osteoarthritis.
