Clinical Efficacy and Safety Profile of Indisetron Tablets in Prevention of Nausea and Vomiting Induced by Chemotherapy Including Cisplatin-Phase II Dose Finding Study-
|
Accession number;05A0015062
|
| Title;Clinical Efficacy and Safety Profile of Indisetron Tablets in Prevention of Nausea and Vomiting Induced by Chemotherapy Including Cisplatin-Phase II Dose Finding Study- |
| Author;
NIITANI HISANOBU
(Nippon Med. Sch.)
FURUE HISASHI
(Teikyo Univ., Sch. of Med.)
TSUKAGOSHI SHIGERU
(Japanese Foundation for Cancer Res., Cancer Chemother. Center, JPN)
KUDO SHOJI
(Nippon Med. Sch.)
NUKARIYA NAOTAKA
(Nippon Med. Sch.)
SAKUMA AKIRA
(Tokyo Medical and Dental Univ., Medical Res. Inst.)
TSUTANI KIICHIRO
(Tokyo Medical and Dental Univ., Medical Res. Inst.)
|
Journal Title;Japanese Pharmacology & Therapeutics
|
Journal Code:Z0947A
|
ISSN:0386-3603
|
|
VOL.32;NO.11;PAGE.823-838(2004)
|
| Figure&Table&Reference;FIG.2, TBL.14, REF.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Objectives: Indisetron is a 5-hydroxytryptamine 3 receptor antagonist and an anti-emetic agent. It shows also 5-hydroxytryptamine 4 antagonistic activity in pharmacological profiles. A randomized open label study was conducted to show dose response profiles in efficacy, safety and usefulness, and to find the optimal dose of indisetron tablets in prevention of acute nausea and vomiting induced by chemotherapy including cisplatin. Methods: 141 malignant tumor patients undergoing cancer chemotherapy including cisplatin (50mg/m2 or above i.v.) received indisetron tablets in this study. Anti-emetic efficacy was evaluated by the classification of severity of nausea and frequency of vomiting episodes at 24 hours after administration of cisplatin planning ahead in the protocol. The safety was evaluated by laboratory test, vital signs, signs and symptoms, and the usefulness was evaluated by combining the efficacy and the safety of patient. Results: Anti-emetic rates ("excellent" and "good") based on the classification of nausea and vomiting were 29.4% in 0.5mg, 65.7% in 4mg, 69.4% in 8mg, and 71.0% in 16mg dose. Therefore, anti-emetic efficacy of indisetron tablets was shown to be dose response. In the safety evaluation based on the incidence of adverse drug reactions, the proportions of "Safe" were 79.4%, 55.6%, 64.9%, and 67.6% respectively and did not showed dose response. In the usefulness evaluation combined efficacy and safety, the proportions of "very useful" and "useful" (rates of usufulness) were 29.4%, 57.1%, 66.7%, and 67.7% respectively and showed dose response. Conclusions: Indisetron tablets were shown dose response profiles in efficacy and usefulness and 8mg as their optimal dose in supportive therapy for chemotherapy including cisplatin. (author abst.) |
|
|
|
Related Articles;
|
|
