The efficacy and safety of palonosetron compared with granisetron in preventing highly emetogenic chemotherapy-induced vomiting in the Chinese cancer patients: a phase II, multicenter, randomized, double-blind, parallel, comparative clinical trial

2008 ◽  
Vol 17 (1) ◽  
pp. 99-102 ◽  
Author(s):  
Zhaocai Yu ◽  
Wenchao Liu ◽  
Ling Wang ◽  
Houjie Liang ◽  
Ying Huang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Patients ◽  
Phase Ii ◽  
Emetogenic Chemotherapy ◽  
Efficacy And Safety ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Comparative Clinical Trial ◽  
Chinese Cancer Patients

scholarly journals Study protocol for an open-label, single-arm, multicentre phase II trial to evaluate the efficacy and safety of combined triplet therapy and olanzapine for prevention of carboplatin-induced nausea and vomiting in gynaecological cancer patients

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024357
Author(s):  
Hirotoshi Iihara ◽  
Mototsugu Shimokawa ◽  
Masakazu Abe ◽  
Yoh Hayasaki ◽  
Yukiyoshi Fujita ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Cancer Patients ◽  
Phase Ii ◽  
Study Protocol ◽  
Phase Ii Trial ◽  
Emetogenic Chemotherapy ◽  
Gynaecological Cancer ◽  
Efficacy And Safety ◽  
Open Label ◽  
Multicentre Phase

IntroductionCarboplatin (CBDCA) administered at a dosage of 4 mg/mL/min or more area under the blood concentration-time curve (AUC) is considered to be ranked as the highest chemotherapy-induced nausea and vomiting (CINV) risk of the moderately emetogenic chemotherapy agents. The complete response (CR) rate for preventing overall CINV, defined as no emetic episodes and no use of rescue medication, for standard triplet antiemetic therapy (5-HT3RA, 5-hydroxytryptamine-3 receptor antagonist; NK1RA, neurokinin-1 receptor antagonist; DEX, dexamethasone) was approximately 60% in gynaecological cancer patients receiving CBDCA-based therapy. Further improvement in antiemetic treatment is needed to optimise care. This trial is to evaluate the efficacy and safety of using 5 mg olanzapine (OLZ) plus standard triplet antiemetic therapy for CINV after AUC ≥4 mg/mL/min CBDCA combination therapy in gynaecological cancer patients.Methods and analysisThis trial is an open-label, single-arm, multicentre phase II trial. Patients who receive CBDCA (AUC ≥4)-based therapy and have never been administered moderate to high emetogenic chemotherapy will be enrolled. All patients will receive OLZ (5 mg oral administration on days 1–4, after supper) in combination with 5-HT3RA, NK1RA and DEX. The primary endpoint is the CR rate during the overall period (0–120 hours). Testing the hypothesis that this regimen can improve CR rate from 60% (null hypothesis) to 75% (alternative hypothesis) with a one-sided type I error of 0.1 and power of 0.8 will require 53 patients. Considering the dropout rate, the target sample size is set at 60.Ethics and disseminationThe study protocol was approved by the institutional review board at each of the participating centres. Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberUMIN000031646.

A double-blind randomized phase II study of 10 versus 5 mg olanzapine for emesis induced by highly emetogenic chemotherapy with cisplatin.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 10111-10111 ◽  
Author(s):  
Hironobu Hashimoto ◽  
Takako Yanai ◽  
Kengo Nagashima ◽  
Natsuko Okita Tsuda ◽  
Hidehito Horinouchi ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Randomized Phase Ii

A Comparative Clinical Trial of Diflunisal and Ibuprofen in the Control of Pain in Osteoarthritis

1979 ◽  
Vol 7 (4) ◽  
pp. 272-276 ◽  
Author(s):  
J G M Keet
Keyword(s):  
Clinical Trial ◽  
Blind Study ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Comparative Clinical Trial ◽  
Treatment Groups ◽  
Ambulatory Patients ◽  
Efficacy Parameters ◽  
Osteoarthritis Of Hip

A randomized double-blind study in ambulatory patients with osteoarthritis of hip and/or knee was conducted, comparing the efficacy and safety of diflunisal 500 mg daily with ibuprofen 1200 mg daily, over a period of 8 weeks. Thirty-five patients participated in the study. The results revealed no significant differences between the treatment groups with regard to the efficacy parameters.

scholarly journals Randomized, Double-Blind, Phase III Study of Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: CONSOLE

2021 ◽  
Author(s):  
Akito Hata ◽  
Isamu Okamoto ◽  
Naoki Inui ◽  
Morihito Okada ◽  
Masahiro Morise ◽  
...  
Keyword(s):  
Adverse Events ◽  
Injection Site ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Injection Site Reactions ◽  
Phase Iii Study

PURPOSE We evaluated the efficacy and safety of fosnetupitant (FosNTP) versus fosaprepitant (FosAPR) for preventing highly emetogenic chemotherapy-induced nausea and vomiting. This phase III study was the first head-to-head comparison between two different neurokinin-1 receptor antagonists in combination with palonosetron and dexamethasone. PATIENTS AND METHODS Patients scheduled to receive cisplatin-based chemotherapy were randomly assigned 1:1 to FosNTP 235 mg or FosAPR 150 mg in combination with palonosetron 0.75 mg and dexamethasone. The primary end point was overall (0-120 hours) complete response (CR; no emetic event and no rescue medication) rate, stratified by sex and age category, to show the noninferiority of FosNTP to FosAPR (noninferiority margin, –10% for the difference in the overall CR rate). RESULTS Overall, 795 patients were randomly assigned, of whom 785 received the study drug (FosNTP [N = 392] v FosAPR [N = 393]) and were evaluated for efficacy and safety. The overall CR rate was 75.2% versus 71.0%, respectively (Mantel-Haenszel common risk difference, 4.1%; 95% CI, –2.1% to 10.3%), demonstrating noninferiority of FosNTP to FosAPR. The CR rates in the acute (0-24 hours), delayed (24-120 hours), and beyond delayed (120-168 hours) phases, and at 0-168 hours were 93.9% versus 92.6%, 76.8% versus 72.8%, 86.5% versus 81.4%, and 73.2% versus 66.9%, respectively. The incidence rates of treatment-related adverse events with FosNTP versus FosAPR were 22.2% versus 25.4%, whereas adverse events or treatment-related adverse events relevant to injection site reactions were 11.0% versus 20.6% ( P < .001) and 0.3% versus 3.6% ( P < .001), respectively. CONCLUSION FosNTP demonstrated noninferiority to FosAPR, with a favorable safety profile and lower risk for injection site reactions. Thus, FosNTP is valuable in the prophylaxis of acute, delayed, and beyond delayed chemotherapy-induced nausea and vomiting.

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