Clinical evaluation of cancer patients who switched from controlled-release morphine sulfate tablets to S-8117 (controlled-release oxycodone hydrochloride tablets)-Phase II clinical study-
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Accession number;05A0310799
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| Title;Clinical evaluation of cancer patients who switched from controlled-release morphine sulfate tablets to S-8117 (controlled-release oxycodone hydrochloride tablets)-Phase II clinical study- |
| Author;
TAKEDA FUMIKAZU
(Saitama Cancer Center, JPN)
YAMAMURA HIDEO
(Kosaikaibyoin)
KOYAMA YASUO
(Tochigi Cancer Center)
TATENO MASAYA
(Japan Red Cross Soc., Toyama Red Cross Hospital, JPN)
HIRAGA KAZUAKI
(Kokuritsuganse Chuobyoin Shujutsubu)
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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.3;PAGE.281-293(2005)
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| Figure&Table&Reference;FIG.1, TBL.12, REF.13 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Objective: To study the efficacy and safety, and usefulness of controlled-release oxycodone hydrochloride tablets (S-8117) in the therapy of cancer pain management, after switching from controlled-release morphine sulfate tablets (MSC) at two-thirds the dose of MSC. Study design: Open-label study. Method: S-8117 was orally administered at 40mg/day and 80mg/day (twice a day) for 3 to 7 consecutive days to 45 patients whose cancer pain was managed with MSC at 60mg/day and 120mg/day, respectively. The pain intensity (CAT: Categorical Scale, VAS: Visual Analogue Scale), number of hours of sleep per day, duration of pain per day, improvement score, safety score, and usefulness score were determined at study entry and at the end of study. The improvement rate, safety rate, and usefulness rate were calculated from each score. Results: 1) There were no significant differences in pain intensities (CAT,VAS), the duration of pain per day, or number of hours of sleep per day between at study entry and at the end of study. The improvement rate was 78.9 % (30/38). After the switch from MSC to S-8117, pain control was maintained in many patients. 2) The incidence of adverse drug reactions (ADRs) was 71.1 % (32/45) at baseline (i.e. before administration of S-8117) and was 60.0 % (27/45) during the treatment of S-8117. The main ADRs reported in this study were sleepiness, constipation, nausea, vomiting and anorexia, and these ADRs are common in opioid analgesics. Abnormal findings in laboratory tests were observed in 26 patients (45 events) and the incidence was 59.1 % (26/44). The causal relationship between abnormal findings in laboratory tests and S-8117 was "probably not related" in all cases. The safety rate was 40.0 % (18/45) and no patients experienced a "serious problem." 3) The usefulness rate was 73.7% (28/38).... (author abst.) |
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