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临床试验/CTRI/2023/04/051951
CTRI/2023/04/051951尚未招募4 期

An open label, single arm, multicenter, prospective study to evaluate safety and effectiveness of Akynzeo® I.V. [Fosnetupitant 235 mg and Palonosetron 0.25 mg (concentrate for solution for infusion)], in the prevention of chemotherapy induced nausea and vomiting (CINV) in Indian patients (STOP-CINV study) - STOP-CINV

Glenmark Pharmaceuticals Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
尚未招募

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1. Patient is scheduled to receive their first chemotherapy cycle of a highly
  • emetogenic or a moderately emetogenic chemotherapy (HEC/MEC).
  • 2. Male/female patients aged above more than or equal to 18 years to less than or equal to 75 years
  • 3. Willing to be part of study and for follow up.
  • 4. Willing to provide written informed consent form.

排除标准

  • 1. Patients with serious cardiovascular disease history or predisposition to
  • cardiac conduction abnormalities or use of medication which can cause
  • conduction abnormalities as per treating physicians’ assessment.
  • 2. Vomiting, retching, or more than no significant nausea within 24 h before
  • the informed consent.
  • 3. Women of child bearing potential who are pregnant, planning to becoming
  • pregnant or breast feeding.
  • 4. Known contraindication to the intravenous administration of 50 mL 5%
  • glucose solution prior to index date
  • 5. Hypersensitivity to active substances or excipients of Akynzeo® I.V.
  • 6. Patient currently enrolled in another clinical trial.
  • 7. Patients requiring multi-day chemotherapy
  • 8. Patients who are prescribed other NK1RA and 5 HT3 RA

研究者

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