Phase III Open Study of 1% Nadifloxacin Ointment for Skin infected Diseases
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Accession number;03A0530034
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| Title;Phase III Open Study of 1% Nadifloxacin Ointment for Skin infected Diseases |
| Author;
OI TSUNAO
(Tokyo Medical College, Hospital)
KAWASHIMA MAKOTO
(Tokyo Women's Medical College, Hospital, JPN)
ISHIGURO NAOKO
(Tokyo Women's Medical College, Hospital, JPN)
IGARASHI ATSUYUKI
(Ntthigashinihon Kantobyoin Hifuka)
ICHIYAMA SHIN'ICHI
(Kokkakomuinkyosaikumiairengokai Yokosukakyosaibyoin Hifuka)
NISHIJIMA SETSUKO
(Kansai Medical Univ., Kori Hospital, JPN)
NOBUTO TOSHIKO
(Kawasaki Medical School, Hospital, JPN)
SENOO AKEMI
(Mitoyosogobyoinkumiai Mitoyosogobyoin)
ARATA JIRO
(Okayama Univ., Medical School, JPN)
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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.19;NO.7;PAGE.743-766(2003)
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| Figure&Table&Reference;FIG.6, TBL.29, REF.10 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To examine safety and efficacy to skin infected diseases of 1% nadifloxacin ointment, Phase III open study was performed in 65 patients with folliculitis, sycosis vulgaris, impetigo cotagiosa, ecthyma vulgaris and secondary skin infections. Based on the results obtained, efficacy rate was 87.3% in efficacy analysis population (55 of the 63 patients), and its 95% confidence interval was 76.5-94.4%. As for bacteriological efficacy, complete eradication was observed in 89.8% of bacteriological analysis population (53 of 59 patients), and its 95% confidence interval was 79.2-96.2%. Complete eradication of isolated strains was seen in 95.5% (85 of 89 strains). Although 16 adverse events were reported in 14 patients of safety analysis population (64 patients), all were judged to be unrelated to the study article. Overall, it was confirmed that this article should be useful to skin infected diseases. (author abst.) |
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