Clinical evaluation of S-8117 (controlled-release oxycodone hydrochloride tablets) in pain control in cancer patients-Single- blind crossover comparative study with controlled-release morphine sulfate tablets-Phase III clinical study-
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Accession number;05A0310800
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| Title;Clinical evaluation of S-8117 (controlled-release oxycodone hydrochloride tablets) in pain control in cancer patients-Single- blind crossover comparative study with controlled-release morphine sulfate tablets-Phase III clinical study- |
| Author;
TAKEDA FUMIKAZU
(Saitama Cancer Center, JPN)
TATENO MASAYA
(Japan Red Cross Soc., Toyama Red Cross Hospital, JPN)
KOYAMA YASUO
(Tochigi Cancer Center)
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.295-313(2005)
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| Figure&Table&Reference;FIG.2, TBL.13, REF.18 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Objective: The primary objective was to demonstrate non-inferiority of controlled-release oxycodone hydrochloride tablets (S-8117) at 40mg/day to controlled-release morphine sulfate tablets (MSC) at 60mg/day for its analgesic effect when used for the treatment of cancer pain. The secondary objective was to compare the safety, efficacy and usefulness between the two drugs. Study design: Single-blind crossover (two-drug, two-period) comparative study. Methods: Seventy-seven patients received either S-8117 twice a day (every 12 hours) for three days (the first period), followed by MSC twice a day (every 12 hours) for three days (the second period), or vice versa. The pain intensity, improvement scores, safety scores and usefulness scores were determined at the end of the first period and the second period. The analgesic effect of S-8117 compared to MSC was analyzed by calculating the 95 % confidence interval for the difference in mean values of the pain intensity based on a crossover analysis of variance. Results: 1) The mean value of the pain intensity was 0.952 for S-8117 and 0.833 for MSC, and the 95% confidence interval for the difference in mean values of the pain intensity was from -0.074 to 0.300. The upper confidence limit was below non-inferiority margin (0.5) and therefore, non-inferiority of S-8117 to MSC was demonstrated in the analgesic effect assessed by the pain intensity (CAT: Categorical Scale). 2) The improvement rate was 85.7% (36/42 patients) for S-8117 and 90.5% (38/42) for MSC. No significant difference was observed between S-8117 and MSC. All of the duration of pain per day, number of hours of sleep per day and the pain intensity (VAS Visual Analogue Scale) after the treatment were similar to those at baseline for both drugs. 3) The safety rate was 22.1% (17/77) for S-8117 and 24.7% (19/77) for MSC. No significant difference was observed between S-8117 and MSC.... (author abst.) |
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