Late Phase II (Dose-Finding) Clinical Study of SS320A.
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Accession number;02A0208994
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| Title;Late Phase II (Dose-Finding) Clinical Study of SS320A. |
| Author;
NAGAOKA SHIGERU
(Japan Res. Inst. Sputum)
TAKISHIMA TAMOTSU
(Tohokudai I Byoin Daiichinaika)
NAGANO HITOSHI
(National Sanatorium Minami Fukuoka Hospital)
KAWAKAMI YOSHIKAZU
(Hokudai I Byoin Daiichinaika)
KITAMURA SATOSHI
(Jichiidai Byoin Kokyukinaika)
KAWAKAMI MASAHIKO
(Tokyotohiroobyoin Kokyukika)
OGURA TAKESHI
(Tokushimadai I Byoin Daisannaika)
SASAKI TAKAO
(Tottoridai I Byoin Daisannaika)
OGAWA NOBUYA
(Ehime 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.1;PAGE.81-107(2002)
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| Figure&Table&Reference;FIG.2, TBL.23, REF.10 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;In patients with chronic respiratory diseases complaining of the difficulty in expectoration of sputum (under relatively stable disease conditions), a dose-finding study of SS320A was conducted by a double-blind manner giving 3 doses (0.6g, 1.2g and 1.8g/day, divided into 3) for 2 weeks. Among a total of 189 cases (0.6g group: 61, 1.2g group: 67 and 1.8g group: 61), the subjected cases for efficacy were 126 (0.6g group: 42, 1.2g group: 48 and 1.8g group: 36), those for safety were 178 (0.6g group: 57, 1.2g group: 64 and 1.8g group: 57), and those for usefulness were 131 (0.6g group: 42, 1.2g group: 50 and 1.8g group: 39), showing no bias among all groups. In the final global improvement rating (evaluated with a index, subjective symptoms related to the difficulty in expectoration of sputum), the rates of cases assessed as "moderately improved" or more were 50%, 79% and 78% in the 0.6g, 1.2g and 1.8g groups, respectively, showing significant differences between 1.8g and 0.6g groups and between 1.2g and 0.6g groups (p=0.014 and p=0.009, respectively). The incidences of adverse reactions were 1.8%, 6.3% and 12.3% in the 0.6g, 1.2g and 1.8g groups, respectively, showing no significant difference among all groups. Major symptoms were digestive organ disorders in all groups, but none of them were serious nor problematic. Incidences of abnormal clinical laboratory findings were 2.3%, 6.1% and 6.4% in the 0.6g, 1.2g and 1.8g groups, respectively, showing no significant difference among all groups. From the above results, the effective rate of SS320A was considered to reach a plateau at 1.2g/day, the useful rate containing safety in the 1.2g group was higher than those in the 0.6g and 1.8g groups, and the safe rate in the 1.8g group was lower than that in 0.6g group, therefore, the recommendable clinical dose of SS320A was judged appropriate to be 1.2g/day (divided into 3). (author abst.) |
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