A randomised double-blind, parallel-group study comparing Olanzapine (ZYPREXA) with Haloperidol (Novo-Peridol) for the relief of Nausea and Vomiting (N&V) in patients with advanced cancer

niversity of British Columbia (Canada)0 个研究点目标入组 80 人开始时间: 2005年6月23日最近更新: 2019年3月4日

试验速览

暂无简介。

•Current inclusion criteria as of 28/01/2008:
•1. Male or female 18 years or older
•2. Significant nausea or vomiting
•3. An expressed need for nausea or vomiting to be relieved with medication
•4. Patient has failed a prior trial with metoclopramide or domperidone
•5. Attempts at addressing probable and possible underlying causes of nausea have been attempted and failed
•6. Sufficient cognitive function
•7. Ability to communicate well with the study personnel and comply with the requirements of the study
•8. Willingness to give written informed consent
•9. Able to take oral medications
•10. Life expectancy estimated to be greater than 2 weeks
•Previous inclusion criteria:
•1. Male or female 18 years or older
•2. Significant nausea or vomiting
•3. An expressed need for nausea or vomiting to be relieved with medication
•4. Patient has failed a prior trial with metoclopramide or domperidone
•5. Attempts at addressing probable and possible underlying causes of nausea have been attempted and failed
•6. Sufficient cognitive function
•7. Ability to communicate well with the study personnel and comply with the requirements of the study
•8. Willingness to give written informed consent

•Current exclusion criteria as of 28/01/2008:
•1. Has partial or complete bowel obstruction
•2. Currently taking haloperidol or olanzapine
•3. Has drug-induced extrapyramidal side effects (as identified by the screening and/or baseline examinations and Modified St. Hans Rating Scale)
•4. Has a known hypersensitivity to haloperidol or olanzapine
•5. Has documented Parkinson's disease
•6. Is undergoing chemotherapy or radiation therapy that includes abdomen, brain, oesophagus or stomach in its field
•7. Has experienced extrapyramidal syndromes (EPS) or intolerance in the past to olanzapine or haloperidol
•8. Concurrently receiving or has received in the last 28 days an investigational drug
•9. Has previously participated in this trial
•Previous exclusion criteria:
•1. Has partial or complete bowel obstruction
•2. Currently taking haloperidol or olanzapine
•3. Has drug-induced extrapyramidal side effects (as identified by the screening and/or baseline examinations and Modified St. Hans Rating Scale)
•4. Has a known hypersensitivity to haloperidol or olanzapine
•5. Has documented Parkinson?s disease
•6. Is undergoing chemotherapy or radiation therapy that includes abdomen, brain, oesophagus or stomach in its field

发起方

niversity of British Columbia (Canada)