Phase III Clinical Study of SS320A. Double-blind Trial in Comparison with Placebo.
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Accession number;02A0208995
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| Title;Phase III Clinical Study of SS320A. Double-blind Trial in Comparison with Placebo. |
| Author;
NAGAOKA SHIGERU
(Japan Res. Inst. Sputum)
TAKISHIMA TAMOTSU
(Tohoku Univ.)
NAGANO HITOSHI
(National Sanatorium Minami Fukuoka Hospital)
KAWAKAMI YOSHIKAZU
(Hokudai I Byoin Daiichinaika)
KITAMURA SATOSHI
(Jichiidai Byoin Kokyukinaika)
KAWAKAMI MASAHIKO
(Tokyotohiroobyoin Kokyukika)
OGURA TAKESHI
(National Sanatorium Toneyama Hospital)
SASAKI TAKAO
(Tottoridai I Byoin Daisannaika)
OGAWA NOBUYA
(Ehime Univ.)
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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.109-140(2002)
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| Figure&Table&Reference;FIG.2, TBL.30, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;In patients with chronic respiratory diseases (chronic bronchitis, bronchiectasis, pulmonary emphysema, latent pulmonary tuberculosis and pneumoconiosis) complaining of the difficulty in expectoration of sputum (under relatively stable disease conditions), a placebo controlled double-blind comparative study of SS320A (giving 1.2g/day, divided into 3, for 2 weeks) was conducted in order to investigate the efficacy and safety as an mucoactive agent. The subjected cases for efficacy were 124 (65 in the SS320A group (S group) and 59 in the placebo group (P group)), those for safety were 153 (S group: 79 and P group: 74), and those for usefulness were 125 (S group: 66 and P group: 59), showing no bias between the 2 groups. In the final global improvement rating (evaluated with main indices, the sense of discomfort of the chest and the difficulty in raising of sputum), the rates of cases assessed as "moderately improved" or more were 65% in the S group and 24% in the P group, and the S group showed a significantly higher improvement than the P group (p.IMAGE.0.000). In the safety rating, the rates of cases assessed as "safe" were 92% in the S group and 92% in the P group, showing no significant difference between the 2 groups (p=0.947). In the usefulness rating, the rates of cases assessed as "useful" or more were 62% in the S group and 24% in the P group, and the S group was significantly superior to the P group (p.IMAGE.0.000). The incidences of adverse reactions were 6.3% in the S group and 2.7% in the P group, showing no significant difference between the 2 groups. (author abst.) |
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