Phase III Study of Valaciclovir Hydrochloride Tablets in Patients with Herpes Simplex. Multi-center, Double-blind Comparative Study with Aciclovir Tablets.
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Accession number;03A0005362
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| Title;Phase III Study of Valaciclovir Hydrochloride Tablets in Patients with Herpes Simplex. Multi-center, Double-blind Comparative Study with Aciclovir Tablets. |
| Author;
KAWASHIMA MAKOTO
(Tokyojoidai Hifuka)
NIIMURA MICHIHIKO
(Jikei Univ. School of Medicine, JPN)
HONDA MARIKO
(Jikei Univ. School of Medicine, JPN)
URUSHIBATA OSAMU
(Tohodai I Dainihifuka)
SHIMADA SHINJI
(Yamanashiidai Hifuka)
TAKIGAWA MASAHIRO
(Hamamatsuidai Hifuka)
MIYACHI YOSHIKI
(Kyodai I Hifuka)
YAMANISHI KOICHI
(Osakadai Daigakuin'igakukeikenkyuka Biseibutsugaku)
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.18;NO.10;PAGE.1155-1175(2002)
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| Figure&Table&Reference;FIG.5, TBL.11, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;For the purpose of examining the efficacy and the safety of valaciclovir hydrochloride (VACV) tablet 500 mg twice daily for five days treatment, a multi-center, double-blind comparative study with aciclovir (ACV) tablets as the active control drug was carried out in 300 patients with herpes simplex including eczema herpeticum, herpes labialis and facial herpes. 1) The efficacy rates (proportion of 'remarkably effective' or 'effective') were 95.9% (141/147 cases) and 89.7% (131/146 cases), in VACV group and ACV group, respectively. Non-inferiority of VACV to ACV was proved (.DELTA.=10%, 95% confidence interval of difference, 0.3-12.1%) and significant difference was found between the two groups (Fisher's exact test: p=0.0439). 2) The safety rates (proportion of 'no problem') were 77.2% (115/149 cases) and 73.0% (108/148 cases), in VACV group and ACV group, respectively. Non-inferiority of VACV to ACV was proved (.DELTA.=10%, 95% confidence interval of difference, -5.6-14.0%). 3) The incidences of adverse drug reaction were 22.1% (33/149 cases) and 26.4% (39/148 cases), in VACV group and ACV group, respectively. The difference between the two groups was not significant (Fisher's exact test: p=0.4191). The above result proved non-inferiority of VACV tablets 500mg twice daily for five days treatment in both efficacy and safety in comparison with ACV tablets 200mg five times daily for five days treatment. The efficacy of the VACV tablets treatment was superior to that of ACV tablets treatment with statistically significant difference. Therefore, it is considered that VACV tablets are drugs of clinical significance with better efficacy, equal safety, less frequency of taking drug and better compliance than ACV tablets. (author abst.) |
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