Multicenter Coordinating Open Trial on FPF3000, Sustained Release Fine Granules of Morphine Sulfate, (Phase II Clinical Trial). The Study on Efficacy and Safety in Treatment of Cancer Pain.
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Accession number;02A0525882
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| Title;Multicenter Coordinating Open Trial on FPF3000, Sustained Release Fine Granules of Morphine Sulfate, (Phase II Clinical Trial). The Study on Efficacy and Safety in Treatment of Cancer Pain. |
| Author;
INAJI HIDEO
(Osakafuseijinbyose Daisangeka)
SAWAMURA TOSHIHIRO
(Osaka National Hospital)
OKA HIROSHI
(Moriguchikeijinkaibyoin Geka)
SAKAUE MASAKI
(Sanseikai Kawachi Sogo Byoin)
KOBAYASHI TETSURO
(Ikeda City Hosp.)
MAEURA GIICHI
(Shin Senri Hospital)
NIWA HIDEKI
(Kikkokai Tane Hospital, JPN)
MONDEN TAKUJI
(Nishi-Nihon Denshin Denwa, Osaka Byoin)
MONDEN MORITO
(Osakadai Daigakuin'igakukeikenkyuka Byotaiseigyogekagaku)
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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.5;PAGE.643-661(2002)
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| Figure&Table&Reference;FIG.4, TBL.11, REF.4 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;FPF3000 is the fine granule preparation of morphine sulfate designed for twice-a-day administration. There are two FPF3000 preparations with different strengths in the active ingredient, the 10 mg (2%) fine granule preparation and the 30 mg fine granule preparation. We report herein the results of the multicenter coordinating open trial conducted to investigate efficacy and safety of FPF3000 in the cancer patients who had been under pain control with a preparation of the sustained release tablet already on market. The patients were administered for 3 days with the same dosage of FPF3000 as a replacement of the sustained release tablet preparation of morphine sulfate, and thereafter returned to the same dosage of the original tablet preparation. The level of their pain symptoms was rated according to Numeric Rating Scale (NRS) by patients themselves, and the investigators made their judgment each patient's pain control state resulting from switching the sustained release tablet preparation to FPF3000 based on the NRS score. Results 1) The number of cases analyzed was 26 cases and 13 cases for the group of FPF3000 10 mg and the group of FPF3000 30 mg, respectively. The number of cases subjected to rating of the pain control state was 25 and 12 cases in the respective groups, the number for assessment of overall safety was 26 and 13 cases, respectively, and the number for efficacy evaluation was 25 and 12 cases, respectively. 2) The ratio of cases rated the score of "Good Pain Control" after replacement of the tablet preparation with FPF3000 for pain treatment was 96.0% for the 10 mg group, and 100% for the 30 mg group. As to NRS scoring, their scores did not vary appreciably in the entire period of the trial. 3) As for the overall safety rating, the cases rated "Safe" were 19.2%, and those rated "Nearly Safe" were 80.8% in the 10 mg group, and the respective ratings were 7.7% and 92.3% in the 30 mg group.... (author abst.) |
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