Early Phase II Study of Valaciclovir Hydrochloride Tablets in Patients with Herpes Simplex.
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Accession number;03A0005360
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| Title;Early Phase II Study of Valaciclovir Hydrochloride Tablets in Patients with Herpes Simplex. |
| Author;
NIIMURA MICHIHITO
(Jikei Univ. School of Medicine, JPN)
KAWASHIMA MAKOTO
(Tokyojoidai Hifuka)
HONDA MARIKO
(Jikei Univ. School of Medicine, JPN)
URUSHIBATA OSAMU
(Tohodai I Dainihifuka)
YAMANISHI KOICHI
(Osakadai Biseibutsubyoken Mashimbumon)
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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.1113-1129(2002)
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| Figure&Table&Reference;FIG.5, TBL.16, REF.5 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A multi-center, unmasked, uncontrolled trial was conducted in order to examine the efficacy, safety and usefulness of valaciclovir hydrochloride (VACV) tablet 500 mg twice daily in the treatment of various herpes simplex virus infections. 1) The number of patients enrolled was 55. Of these, 2 patients were excluded from ITT (intent to treat) analysis and 5 patients were excluded from PC (protocol compatible) analysis. In 48 subjects of PC analysis set 45, 48 and 45 cases were included in efficacy, safety and usefulness analysis, respectively. 2) The efficacy rate (proportion of cases evaluated as 'remarkably effective' or 'effective') was 93.3 % (42/45 cases). 3) The safety rate (proportion of cases evaluated as 'no problem') was 91.7% (44/48 cases). 4) The incidence of adverse reaction (symptomatic) was 4.2% (2/48 cases, 3 events). All these symptoms were mild. The incidence of adverse reaction (abnormal change of laboratory test value) was 4.2% (2/48 cases, 2 events). It was speculated that underlying disease might cause both of them. 5) The usefulness rate (proportion of cases evaluated as 'remarkably useful' or 'useful') was 88.9% (40/45 cases). The efficacy and safety of VACV tablet 500 mg twice daily in the treatment of various herpes simplex virus infections, including labial herpes, facial herpes, eczema herpeticum, herpetic whitlow, genital herpes and buttock herpes were confirmed by the above result. (author abst.) |
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