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临床试验/CTRI/2017/10/010163
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

发起方
Dr Nenavath Vinay

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