Results of phase III clinical study on TS-110 against lumbago-related diseases, cervico brachial syndrome, and scapulohumeral periarthritis. Double blind comparative study using diclofenac sodium as a control.:—<I>Double blind comparative study using dicl
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We compared TS-110 4 mg, 3times daily with a control drug, diclofenac sodium 25 mg, 3times daily in a double-blind study in order to evaluate clinical utility of TS-110 against lumbago-related disease, cervico-brachial syndrome and scapulohumeral periarthritis.<BR>1. Concerning the final overall improvement rating, the improvement rate (the percentage of the patients graded as"inproved"or better) was 60.8% (76/125) and 55.7/ (73/131) in Groups T and D, respectively, suggesting the same level of efficacy in Groups T and D.<BR>2. As to the global safety rating, the safety rate (the percentage of patients in whom the drug was graded as"safe") was 77.8% (112/144) and 73, 4% (116/158) in Groups T and D, respectively.<BR>3. With respect to utility rating, the utility rate (the percentage of patients in whom the drug was graded as"useful"or better) was 58.1% (72/124) and 46.6% (61/131) in Groups T and D, suggesting the same level of usefulness in Groups T and D.<BR>The utility rate obtained by ITT analysis was 56.2% (82/140) and 42.7% (70/164) in Groups T and D, respectively, with the utility rate in Group T significantly higher than that in Group D (p=0.0178) .<BR>4. A total of 38 cases of adverse reactions were noted in 32 of 148 patients (21.6%) in Group T, and 68 cases in 46 of 164 patients (28.0%) in Group D. As to the breakdown of symptoms, 27 and 38 cases of gastrointestinal symptoms were noted in Groups T and D, respectively, one case of drug eruption was noted in Group D, two and ten cases of symptoms in the mental and nervous systems in Groups T and D, respectively, and five and seven cases of other adverse reactions in Groups T and D, respectively. Four and 12 cases of abnormal clinical laboratory test values in Groups T and D, respectively, were judged to be adverse reactions. None of these adverse reactions, however, were severe.<BR>In light of these findings, TS-110 was judged to have the same level of efficacy and safety as diclofenac sodium against lumbago-related diseases, cervicobrachial syndrome and scapulohumeral periarthritis, and thus, to be a clinically highly useful drug.
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