Dose Finding Study of Seratrodast, a Thromboxane A2 Antagonist, in Patients with Perennial Allergic Rhinitis. A Multi-center, Double-blind Comparative Study.
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Accession number;99A0315569
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| Title;Dose Finding Study of Seratrodast, a Thromboxane A2 Antagonist, in Patients with Perennial Allergic Rhinitis. A Multi-center, Double-blind Comparative Study. |
| Author;
SAKAKURA YASUO
(Mie Univ., Sch. of Med.)
UNNO TOKUJI
(Asahikawa Med. Coll.)
TAKASAKA TOMONORI
(Tohoku Univ., Sch. of Med.)
BABA KOTARO
(Dokkyo Univ. Sch. of Med.)
OYAMA MASARU
(Kagoshima Univ., Fac. of Med.)
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.15;NO.2;PAGE.213-245(1999)
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| Figure&Table&Reference;FIG.4, TBL.25, REF.7 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Seratrodast at 4mg/day, 40mg/day or 80mg/day was given once daily for 4 weeks in a double-blind comparative study to determine the optimal clinical dose for treating perennial allergic rhinitis. Results obtained were as follows. 1) In final improvement rate evaluation of nasal symptoms, primary end point, "moderate improvement" or better was 36.8% (28/76) in the 4mg/day group, 38.4% (28/73) in the 40mg/day group, and 45.3% (34/75) in the 80mg/day group, demonstrating increasing improvement rate dose-dependently. No significant difference was shown using the one-sided Cochran-Armitage test (p=0.144). 2) In the subject group whose main complaint was nasal obstruction, where nasal symptoms concerning nasal obstruction were the key item when evaluating improvement, and duration of disease was one year or longer, improvement rate in nasal symptoms (final evaluation) was similarly dose-proportional. 3) Compilation of diary data: changes in diary scores on nasal obstruction also increased dose-dependently, demonstrating efficacy in treating nasal obstruction. 4) Safety evaluation: incidence of signs and symptoms where causality with the test drug could not be denied were 2.5% (2/79) in the 4mg/day group, 5.1% (4/78) in the 40mg/day group, and none in the 80mg/day group. On the other hand, abnormal changes in laboratory data where causality with the test drug could not be denied were seen in 5.1% (4/79) in the 4mg/day group, 6.4% (5/78) in the 40mg/day group, and 7.4% (6/81) in the 80mg/day group, showing no significant difference among groups. No serious events were observed in any of the groups. Based on the above results, it is suggested that 80mg of seratrodast may be the daily dose for treating perennial allergic rhinitis. (author abst.) |
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