Clinical Study to Investigate the Optimal Dosage of Epinastine Hydrochloride Dry Syrup in Pediatric Patients with Bronchial Asthma-Late Phase II, Multicenter Double-blind, Comparative Study-
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Accession number;05A0100731
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| Title;Clinical Study to Investigate the Optimal Dosage of Epinastine Hydrochloride Dry Syrup in Pediatric Patients with Bronchial Asthma-Late Phase II, Multicenter Double-blind, Comparative Study- |
| Author;
MIKAWA HARUKI
(Kansai Electric Power Co., Inc., Hospital, JPN)
BABA MINORU
(Fratern. Memol. Hosp.)
NAKASHIMA MITSUYOSHI
(Hamamatsu Univ. Sch. 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.21;NO.1;PAGE.63-88(2005)
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| Figure&Table&Reference;FIG.5, TBL.14, REF.55 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The double-blind, parallel-group, comparative study was conducted in child patients with mild to moderate childhood bronchial asthma to examine the optimal dose of Epinastine hydrochloride dry syrup. Among 139 subjects receiving the study drugs, 120 were included in the primary efficacy analysis population. The study drug was administered once daily for 6 weeks. The dose groups were defined as follows based on the administered dosage relative to body weight: < 0.26mg/kg as L group, .GEQ. 0.26mg/kg < 0.42mg/kg as M group and .GEQ. 0.42mg/kg as H group. The mean values of symptom scores and treatment scores were obtained every 2 weeks. The dose-response was investigated by the difference from baseline at Weeks 2, 4 and 6 after the first dosing. Symptom scores, which were defined as the primary endpoint in the study, were significantly decreased at Week 2 from baseline. Further decreases were observed at Weeks 4 and 6. No dose-response was however detected among the above three groups. Daily life scores and Nighttime sleep scores (the secondary endpoints) were decreased from their baseline: however, no dose-response was detected. There was no dose-response for the impression of patients or his/her parents, overall improvement or final overall improvement, neither. Peak flow rate was improved from baseline but no dose-response was detected. The major adverse reactions observed in the study were somnolence in 3 subjects (2.16%) consisted of 1 patient in M group, 2 patients in H group; bitterness (preferred term: taste disturbance) in 3 subjects (2.16%) consisted of 1 patient in L group, 2 patients in M group. No dose-response was seen among three groups in terms of the frequency of adverse reaction. (author abst.) |
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