Phase III Study of TAU-284 (Bepotastine Besilate) on Chronic Urticaria. A Multicenter Double Blind Comparative Study with Placebo.
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Accession number;02A0429244
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| Title;Phase III Study of TAU-284 (Bepotastine Besilate) on Chronic Urticaria. A Multicenter Double Blind Comparative Study with Placebo. |
| Author;
KAWASHIMA MAKOTO
(Tokyojoidai Hifuka)
HARADA SHOTARO
(Higashi-Nihon Denshin Denwa, Kanto Byoin)
NAKASHIMA MITSUYOSHI
(Hamamatsu Univ. Sch. of Med.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.18;NO.4;PAGE.501-519(2002)
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| Figure&Table&Reference;FIG.8, TBL.12, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy of TAU-284 at a recommended dose of 20mg daily was examined for the treatment of chronic urticaria patients in a placebo-controlled double blind parallel study. TAU-284 at 5mg was also given to the patients to investigate dose-response properties of the agent. 1) The total number of subjects was 160:55 in the 20mg/day group (Group H), 51 in the 5mg/day group (Group L), and 54 in the placebo group (Group P). All the subjects were analyzed. 2) As for changes in scores before and after administration, "Itching level" was -1.62 for Group H, -1.24 for Group L, and -0.15 for Group P, showing significant difference between Groups H and P, and Groups L and P (The infinite least significant difference method, LSD: p<0.0001, p<0.0001). No significant difference was found between Groups H and L (p=0.0685). "Appearance of skin lesion (eruption)" was -1.49 in Group H, -1.16 in Group L, and -0.46 in Group P (The infinite LSD method: p<0.0001, p=0.0001), showing significant difference between Groups H and P, and Groups L and P. No significant difference was found between Groups H and L (p=0.0568). 3) In global improvement rating, "Moderately improved" or better was 69.1% in Group H, 47.1% in Group L, and 7.4% in Group P, indicating that Groups H and L were significantly superior to Group P (Fisher's exact test: p<0.0001, p<0.0001). Group H was significantly improved than Group L (p=0.0299). 4) Incidence of adverse events where causality with the test drug could not be denied was 21.8% in Group H, 23.5% in Group L, and 16.7% in Group P. No significant differences were confirmed regarding adverse events. 5) In Groups H and L, sleepiness, one of the adverse events, was seen in 6.6%, resulting in that the test drug is likely to cause less sleepiness. These results confirm the efficacy of TAU-284 at a recommended dose of 20mg daily in treating chronic urticaria.... (author abst.) |
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