A study of the safety and efficacy of eight-week administration of S-8117 (controlled-release oxycodone hydrochloride tablets) in opioid-naive cancer patients-Phase III clinical study-
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Accession number;05A0310801
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| Title;A study of the safety and efficacy of eight-week administration of S-8117 (controlled-release oxycodone hydrochloride tablets) in opioid-naive cancer patients-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.315-333(2005)
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| Figure&Table&Reference;FIG.4, TBL.12, REF.9 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Objective: The primary objective was to evaluate the safety and efficacy of controlled-release oxycodone hydrochloride tablets (S-8117) at one week after the start of administration in opioid-naive cancer patients. The secondary objective was to determine the pain control achievement rate and evaluate the long-term safety and efficacy of S-8117 in opioid-naive patients. Study design: Open-label study. Method: S-8117 was orally administered to ninety-two patients at the initial dose of 10mg at one time, twice a day (20mg/day). The dose was titrated up and/or down at an interval of 24 hours to maintain the state of pain control based on the balance between each patient's pain intensity and the severity of adverse drug reactions. Consequently, patients tolerated oral S-8117 up to 8 consecutive weeks maximum. The pain intensity, improvement scores and safety scores were determined. Results: 1) The improvement rate at one week after the start of administration was 90.7 % (39/43) and the 95 % confidence interval was 77.9-97.4 %. 2) Pain control was achieved in 69.1 % (47/68), the mean daily dose at the time of achievement was 25.1mg and the mean time to achievement (the mean number of days required for dose adjustment) was 5.0 days (2.0 days). Among the 47 patients who achieved pain control, 38 patients (80.9 %) achieved pain control without titrating up the dose from the initial dose (20mg/day). 3) The pain intensity at one week after the start of administration and on achievement of pain control (both categorical scale and visual analog scale), the duration of pain per day, and the number of hours of sleep per day were all significantly improved, as compared with at baseline and remained the same until 8 weeks. 4) The safety rate at one week after the start of administration was 19.8 % (18/91) and the 95 % confidence interval was 12.2-29.4 %.... (author abst.) |
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