CTRI/2017/10/010163已完成3 期
A Comparative Randomised Controlled Trial of Granisetron vs Ondansetron in Prevention of Chemotherapy Induced Nausea and Vomiting â?? An Open Label Parallel Group Study
Dr Nenavath Vinay0 个研究点目标入组 94 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
- 94
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
- •Inclusion Criteria:
- •1.Patients aged between 20 yrs and 65 yrs of both sexes at the time when they are giving consent
- •2.Diagnosed as cancer patients by the Medical Oncologist are only taken for the study
- •3.Be naïve to chemotherapy or been treated with single cycle of Chemotherapy with Moderate Emetogenicity and Low emetogenicity Chemotherapeutic agents
- •4.Patient who were scheduled to receive chemotherapy with any dose of Moderate or Low emetogenic potential chemotherapeutic agents except Carboplatin
排除标准
- •Exclusion Criteria:
- •1.Known Allergic to Ondansetron or Granisetron or Dexamethasone
- •2.Patients who are too sick to give informed consent
- •3.Patients having baseline prolong QTc interval with arrythmias and conduction defects
- •4.Patients with Severe and uncontrollable complications
- •5.Patients with abnormal Serum levels of Potassium, Calcium and Magnesium will be excluded
- •6.Patients with Metastasis to brain which are symptomatic
- •7.Patients with Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity
- •8.Symptomatic or invasive procedure indicated ascites or pleural effusion
- •9.Patients having either gastric outlet stenosis or intestinal obstruction
- •10.Patients having Ongoing emesis or greater nausea
- •11.Liver failure and Kidney failure patients
- •12.Pregnant women and Lactating mothers
- •13.Any male or female who is not willing to practice adequate contraceptive measures during the study period
- •14.Subject who is currently enrolled in another investigational drug study
研究者
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