Phase III Open-labeled Study of Epinastine Hydrochloride Dry Syrup in Pediatric Patients with Atopic Dermatitis - Evaluation of Safety for 3 Months Administration -
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Accession number;03A0865487
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| Title;Phase III Open-labeled Study of Epinastine Hydrochloride Dry Syrup in Pediatric Patients with Atopic Dermatitis - Evaluation of Safety for 3 Months Administration - |
| Author;
HARADA SHOTARO
(Nippon Telegraph and Telephone East Corp., Kanto Medical Center, JPN)
NAKAGAWA HIDEMI
(Jichi Medical School, Hopital, JPN)
ONODA SUSUMU
(Onodahifuka)
MATSUOKA YOSHITAKA
(Matsubarahifuka)
OJI MASATAKA
(Ojihifuka)
KITAHARA HIROTO
(Kitaharahifuka)
TSUTSUMI MASAHIKO
(Tsutsumikurinikku)
ABE MASANORI
(Abehifuka)
FUKUNAKA HIDENORI
(Fukunakahifuka)
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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.11;PAGE.1307-1325(2003)
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| Figure&Table&Reference;FIG.5, TBL.16, REF.26 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;This study was designed to evaluate the safety of Epinastine hydrochloride dry syrup in the treatment of atopic dermatitis in children in terms of the frequency of adverse events (including abnormal changes in laboratory measurements) during 12 weeks and the efficacy on pruritus associated with atopic dermatitis in children, as a secondary endpoint. The plasma drug concentrations of Epinastine hydrochloride were also evaluated as another secondary endpoint. The frequency of adverse events throughout the administration period was 56.45% (35 out of the 62 patients). The frequency of adverse events by onset time were 27.42% (17 out of the 62 patients) at less than 28 days after administration, 24.19% (15 out of the 62 patients) from 28 days to less than 56 days, 19.35% (12 out of the 62 patients) from 56 days to less than 84 days and 2.22% (1 out of the 45 patients) at 84 days or more. The frequency did not increase over time. The frequency of adverse events throughout the administration period was the highest in nasopharyngitis, i.e., 20.97% (13 out of the 62 patients). Patients in whom the administration was discontinued because of adverse events were 2 out of the 62 patients (3.23%), but the relationship with the study drug was denied by the investigator in these patients. The frequency of somnolence and malaise which are important adverse events was 4.84% (3 out of the 62 patients) and the adverse events by onset time were somnolence in 1 patient at less than 28 days after administration, malaise in 1 patient from 28 days to less than 56 days, and somnolence in 1 patient from 56 days to less than 84 days. The adverse reaction observed in this study was only somnolence of which the frequency was 1.61% (1 out of the 62 patients). The number out of the patients in whom abnormal laboratory values after administration were regarded as adverse events was 4 out of the 62 patients and the relationship with the study drug was denied in all these patients.... (author abst.) |
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