Late Phase II Study of Valaciclovir Hydrochloride Tablets in Patients with Eczema Herpeticum. Optimal Dose Finding Study by Double-blind Comparative Trial.
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Accession number;03A0005361
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| Title;Late Phase II Study of Valaciclovir Hydrochloride Tablets in Patients with Eczema Herpeticum. Optimal Dose Finding Study by Double-blind Comparative Trial. |
| Author;
NIIMURA MICHIHITO
(Jikei Univ. School of Medicine, JPN)
NISHIKAWA TAKEJI
(Sch. of Med., Keio Univ.)
KAWASHIMA MAKOTO
(Tokyojoidai Hifuka)
HONDA MARIKO
(Jikei Univ. School of Medicine, JPN)
URUSHIBATA OSAMU
(Tohodai I Dainihifuka)
YOSHIKAWA KUNIHIKO
(Osakadai I Hifuka)
YAMANISHI KOICHI
(Osakadai I Saikingaku)
NAKASHIMA MITSUYOSHI
(Hamamatsuidai Yakurigaku)
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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.18;NO.10;PAGE.1131-1154(2002)
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| Figure&Table&Reference;FIG.5, TBL.15, REF.18 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;In order to determine a clinically optimal dose of valaciclovir hydrochloride tablets for herpes simplex, the efficacy, safety and usefulness of valaciclovir were investigated in a double-blind, comparative study in patients with eczema herpeticum, a type of herpes simplex, by use of three treatment groups (500mg, 1000mg or 2000mg daily: 250mg, 500mg or 1000mg twice daily for five days treatment). 1) The total number of patients enrolled was 152. Of these, 13 patients were excluded from ITT (intent to treat) analysis and a patient was excluded from PC (protocol compatible) analysis. In 138 cases of PC analysis set 123, 131 and 117 cases were included in efficacy, safety and usefulness analysis, respectively. 2) The efficacy rates (proportion of cases evaluated as 'remarkably effective' or 'effective') were 78.9%, 90.0% and 95.6 % in the 500mg group, the 1000mg group and the 2000mg group, respectively, showing that the efficacy rate was dose-dependent (Cochran-Armitage test: contrast-1,0,1 p=0.0145, contrast-2,1,1 p=0.0288). Statistically significant difference was found in the efficacy rate between the 500mg group and the 2000mg group (p=0.0206), when chi-square test was carried out in comparison with the 500mg group. 3) The safety rates (proportion of cases evaluated as 'no problem') were 95.1%, 95.6% and 91.1% in the 500mg group, the 1000mg group and the 2000mg group, respectively. No statistically significant difference was found among these groups, when chi-square test was carried out in comparison with the 500mg group. 4) The incidences of adverse drug reaction (symptomatic) were 12.2%, 2.2% and 4.4% in the 500mg group, the 1000mg group and the 2000mg group, respectively. All these symptoms were mild or moderate and no serious cases were observed. The incidences of adverse drug reaction (abnormal change of laboratory test) were 4.9%, 15.6% and 13.3% in the 500mg group, the 1000mg group and the 2000mg group, respectively.... (author abst.) |
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