CTRI/2018/08/015210已完成3 期
Olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced nausea and vomiting in children: a randomised phase 3 trial
Cancer Institute0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients between 5-18 years of age
- •2. Receiving NK-1 inhibitor (Aprepitant/Fosaprepitant) and 5HT-3 antagonist (ondansetron/palnosetron) and/or dexamethasone as prophylactic anti-emetics for CINV due to moderate to highly emetogenic chemotherapy (Appendix A and B).
- •3. Parents/guardian providing written consent to participate in the study.
- •4. Patients who develop breakthrough vomiting after starting prophylactic anti-emetics
- •5. Patients should have no history of CNS disease including brain metastasis, seizure disorder or psychosis
- •6. Patient should not be on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine or phenothiazine.
- •7. Lansky performance scale of above 50 or ECOG performance scale less than 3.
排除标准
- •1. Patient, allergic to olanzapine or metoclopramide
- •2. Patient has renal failure, congestive heart failure or any uncontrolled disease except for malignancy
- •3. Patient has diabetes mellitus
- •4. SGOT/SGPT >4 x upper limit of normal (ULN) and Bilirubin >1.5 x ULN
- •5. Serum creatinine > ULN
研究者
相似试验
招募中
2 期
Comparison of the effectiveness of olanzapine, metoclopramide and domperidone for controlling chemotherapy related nausea and vomitingCTRI/2018/11/016359Jawaharlal Institute Of Postgraduate Medical Education and Research
已完成
3 期
Metoclopramide versus ondansetron for preventing nausea and vomiting after cesarean sectioIRCT20220502054722N1Vice-Chancellery for Research, Hormozgan University of Medical Sciences150
招募中
3 期
Comparison of - Isopropyl Alcohol aromatherapy versus intravenous dexamethasone on incidence of Postoperative Nausea and Vomiting in patients undergoing Elective Laparoscopic Gynaecological Surgeries: A Randomized Clinical TrialCTRI/2023/09/057841Jawaharlal Institute of Postgraduate Medical Education and ResearchJIPMER
Unknown
2 期
Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer CareNauseaVomitingEnd Stage CancerNCT03679182Khon Kaen University15
进行中（未招募）
不适用
COMFORT-study Comparison of Olanzapin and Metoclopramide For treatment Of bReakThrough emesis - COMFORTPatienten, die trotz maximaler Standardantiemese mit Granisetron, Dexamethason und Aprepitant unter chemotherapie-induzierter Übelkeit und Erbrechen leiden.MedDRA version: 12.1Level: LLTClassification code 10028813Term: NauseaMedDRA version: 12.1Level: LLTClassification code 10014542Term: EmesisEUCTR2010-018665-30-DEMartin-Luther University Halle-Wittenberg86