title: A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy.
abstract: OBJECTIVE
  This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting.
  
  
  METHODS
  This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6.
  
  
  RESULTS
  Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events.
  
  
  CONCLUSIONS
  In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups.
authors: Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea College of Medicine, Suwon, Korea.
authors: Hee Yeon
authors: HY
authors: Lee
authors: Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea College of Medicine, Suwon, Korea.
authors: Hoon-Kyo
authors: HK
authors: Kim
authors: Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Korea.
authors: Kyung Hee
authors: KH
authors: Lee
authors: Department of Internal Medicine, Seoul Veterans Hospital, Seoul, Korea.
authors: Bong-Seog
authors: BS
authors: Kim
authors: Department of Internal Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.
authors: Hong Suk
authors: HS
authors: Song
authors: Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.
authors: Sung Hyun
authors: SH
authors: Yang
authors: Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.
authors: Joon Hee
authors: JH
authors: Kim
authors: Department of Internal Medicine, Korea University Anam Hospital, Korea University School of Medicine, Seoul, Korea.
authors: Yeul Hong
authors: YH
authors: Kim
authors: Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.
authors: Jong Gwang
authors: JG
authors: Kim
authors: Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Sang-We
authors: SW
authors: Kim
authors: Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Dong-Wan
authors: DW
authors: Kim
authors: Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, Seoul, Korea.
authors: Si-Young
authors: SY
authors: Kim
authors: Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.
authors: Hee Sook
authors: HS
authors: Park
keywords: Antineoplastic agents; Azasetron; Ondansetron; Serotonin antagonists; Vomiting; Vomiting/chemically induced; Vomiting/prevention and control