A multi-centre, randomised, phase IV study to compare the efficacy of oxycodone/naloxone verses oxycodone prolonged release tablets in patients with advanced cancer

Peter MacCallum Cancer Centre0 个研究点目标入组 37 人开始时间: 2019年9月17日最近更新: 2022年11月21日

适应症

试验速览

暂无简介。

•1. Patient has provided written informed consent
•2. Aged 18 years or older at the time of informed consent
•3. Metastatic (Stage IV) or unresectable solid tumour or haematological malignancy
•4. Patient has moderate to severe cancer-related pain defined as a numeric pain rating score of greater than or equal to 4 requiring commencement of Oxy PR 20-160mg per day or OXN PR 20/10 – 160/80mg per day either as first prolonged release opioid or switched from a different opioid, as determined by the investigator
•5. Patients must have adequate organ function within 14 days of randomisation:
•Defined by:
•- Serum alanine aminotransferase less than 2.5 x upper limit of normal (ULN) and/or serum bilirubin less than 2.5 x ULN
•- Serum albumin greater than or equal to 20g/L
•- Estimated Glomerular Filtration Rate greater than or equal to 50mL/min (using CKD-EPI calculation)
•6. Able to swallow oral medications
•7. Able to complete study assessments
•8. Has a life expectancy of at least 12 weeks

•1.Patients with known liver metastasis
•2.Clinically significant gastrointestinal disease including inflammatory bowel disease, intestinal obstruction or pseudo-obstruction, active diverticular disease, gastrointestinal haemorrhage, history of bowel perforation, history of ischaemic colitis
•3.New chemotherapy or immunotherapy treatment starting within 14 days prior to randomisation
•4.Radiotherapy to any abdominal area or site of pain within 4 weeks of randomisation
•5.Enrolment on another clinical trial with an investigational agent for pain within 30 days of randomisation. (Enrolment in other non-pain investigational studies during this study is permitted, including chemotherapy and immunotherapy trials)

发起方

Peter MacCallum Cancer Centre