Clinical Evaluation of Seratrodast, a Thromboxane A2 Antagonist, in Patients with Perennial Allergic Rhinitis. Multi-center Comparative Double-blind Test with Terfenadine.
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Accession number;99A0315571
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| Title;Clinical Evaluation of Seratrodast, a Thromboxane A2 Antagonist, in Patients with Perennial Allergic Rhinitis. Multi-center Comparative Double-blind Test with Terfenadine. |
| 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.267-307(1999)
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| Figure&Table&Reference;FIG.8, TBL.26, REF.25 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy and safety of AA-2414, a thromboxane A2 antagonist, at 80mg/day in patients with perennial allergic rhinitis were compared with those of Terfenadine, a reference drug, at 120mg/day in a double-blind test in order to verify the non-inferiority of AA-2414 to Terfenadine. The following results were obtained: 1) A total of 234 patients (AA group: 113, TE group: 121) were enrolled in the study. Of these, 211 patients (AA group: 101, TE group: 110) were included in the Per Protocol Set, 230 patients (AA group: 111, TE group: 119) included in the Full Analysis Set, and 231 patients (AA group: 111, TE group: 120) included in the safety analysis. 2) In the patients included in the Per Protocol Set, improvement rates ("moderate improvement" or better) of nasal symptoms (primary endpoint) at the final evaluation were 55.4% in AA group and 30.9% in TE group. The main analysis by non-inferiority test confirmed the non-inferiority of AA group to TE group (p<0.001). The secondary analysis by x2 test demonstrated significant superiority of AA group to TE group in nasal symptom improvement (p=0.001). 3) Of nasal symptoms evaluated (nasal obstruction, nasal discharge and sneezing), improvement of nasal obstruction was considered as the characteristic effect of AA-2414. When the improvement rate ("moderate improvement" or better) of nasal obstruction at the final evaluation was compared, AA group was significantly superior to TE group, 51.4% vs. 34.7% (p=0.016). Improvement rates ("moderate improvement" or better) of nasal discharge and sneezing were also higher in AA group than in TE group. 4) The stratified analysis of nasal symptom improvement ratings demonstrated that improvement rates of severe nasal symptoms and severe nasal obstruction were significantly higher in AA group than in TE group. 5) In the safety analysis, the incidence of adverse events whose causal relationships to the test drugs could not be denied were 6.3% in AA group and 8.... (author abst.) |
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