A Study on Efficacy and Safety of 20mg/day, 40mg/day, 80mg/day of Seratrodast, a Thromboxane A2 Receptor Antagonist on Perennial Allergic Rhinitis Patients. An Early Phase II Study.
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Accession number;99A0315567
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| Title;A Study on Efficacy and Safety of 20mg/day, 40mg/day, 80mg/day of Seratrodast, a Thromboxane A2 Receptor Antagonist on Perennial Allergic Rhinitis Patients. An Early Phase II Study. |
| Author;
ISHIKAWA TAKERU
(Kumamoto Univ., Med. Sch.)
UNNO TOKUJI
(Asahikawa Med. Coll.)
BABA KOTARO
(Dokkyo Univ. Sch. of Med.)
SAKAKURA YASUO
(Mie Univ., Sch. of Med.)
OYAMA MASARU
(Kagoshima Univ., Fac. 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.15;NO.2;PAGE.147-182(1999)
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| Figure&Table&Reference;FIG.6, TBL.17, REF.26 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;AA-2414, a thromboxane A2 receptor antagonist, was orally given to patients with perennial allergic rhinitis at doses of 20mg, 40mg or 80mg after dinner for 4 weeks following a 1-week control observation period, to determine the efficacy, safety, and effective range of the agent. The total number of subjects was 49 for the 20mg group, 51 for the 40mg group, and 55 for the 80mg group, giving an overall number of 155 subjects. The results obtained were as follows. 1) At the final evaluation, improvement rates for nasal obstruction, nasal discharge and sneezing showing "marked improvement" or better in the 20mg, 40mg, and 80mg daily doses were, respectively, 22.5% (9/40), 25.6% (11/43), and 33.3% (15/45) for nasal obstruction, 16.7% (7/42), 20.0% (9/45), and 22.7% (10/44) for nasal discharge, and 9.1% (4/44), 23.3% (10/43), and 28.9% (13/45) for sneezing. All the three symptoms showed higher improvement rates dose-dependently. Compared with published data for terfenadine and epinastine, recently developed antiallergic agents, improvement rates in nasal discharge and sneezing of the 20mg group were lower than the data for terfenadine and epinastine, but the 40mg and 80mg groups showed equal or higher improvement rates in all three symptoms. Notably, improvement in nasal obstruction in the 40mg and 80mg groups was higher than that of terfenadine and epinastine. 2) Incidence of side effects (subjective and objective symptoms and abnormal changes in laboratory test values) were 21.7% (10/46), 13.7% (7/51), and 9.6% (5/52) for 20mg, 40mg, and 80mg, respectively, showing no pattern. Subjective and objective symptoms included gastrointestinal disorders such as stomachache, diarrhea, and dry mouth, and dermal symptoms such as eruption and pruritus. Abnormal changes in laboratory test values included liver function abnormalities such as increases in GOT and GPT; however, there were no problematic events.... (author abst.) |
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