None listed
Conditions
Brief summary
This study aims to evaluate two pain relief medications, oxycodone/naloxone prolonged-release (OXN PR) and oxycodone alone prolonged-release (Oxy PR). The study will assess how effective these medications are at relieving pain and reducing constipation in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have metastatic cancer (Stage IV) and moderate to severe pain. Study details All participants will be randomly assigned (by chance) to either receive a combination drug of oxycodone/naloxone or oxycodone alone. In both groups participants will take two tablets a day, however this dosage may be adjusted if needed by your treating clinician. The study will involve a variety of questionnaires exploring Pain, Quality of life and Bowel movement over a 5 week period initially and if you decide to continue on the study for a total of 11 weeks. It is hoped this study can provide insight into the clinical effectiveness between the two pain medications and their effect on sustained analgesia and bowel function. This study may provide greater knowledge into how pain is treated in patients with advanced cancer.
Interventions
The study drugs used in this trial are oxycodone/naloxone prolonged release (OXN PR) and oxycodone prolonged release tablets (Oxy PR). The trial is designed to demonstrate equivalence between OXN PR and Oxy PR with respect to analgesic efficacy based on average pain over the last 24 hours as measured by the Brief Pain Inventory – Short Form (BPI-SF) and to demonstrate superiority of constipation management in oxycodone/naloxone prolonged release (OXN PR) compared to oxycodone prolonged release
The study drugs used in this trial are oxycodone/naloxone prolonged release (OXN PR) and oxycodone prolonged release tablets (Oxy PR). The trial is designed to demonstrate equivalence between OXN PR and Oxy PR with respect to analgesic efficacy based on average pain over the last 24 hours as measured by the Brief Pain Inventory – Short Form (BPI-SF) and to demonstrate superiority of constipation management in oxycodone/naloxone prolonged release (OXN PR) compared to oxycodone prolonged release tablets (Oxy PR) amongst cancer patients with pain. This is a multi-centre, open-label, randomised, phase IV study of oxycodone/naloxone prolonged-release (OXN PR) or oxycodone alone prolonged-release (Oxy PR) in patients with metastatic (Stage IV) solid tumours or haematological malignancies with cancer-related pain. Following randomisation to either ARM 1, oxycodone/naloxone prolonged-release (OXN PR) or ARM 2, oxycodone alone prolonged-release (Oxy PR), patients will enter the main study phase for 5 weeks. During the first week, the dose of oxycodone alone prolonged-release (Oxy PR) or oxycodone/naloxone prolonged-release (OXN PR) will be titrated to analgesic effect. The dose range is Oxy PR 20-160 mg per day or OXN PR 20/10 - 160/180 mg per day either as first prolonged release opioid or switched from a different opioid, as determined by the investigator. The investigator together with the participant will subjectively determine that the analgesic effect has been reached in week 1 of the study. Week 1 is followed by a 4-week assessment period with oxycodone alone prolonged-release (Oxy PR) or oxycodone/naloxone prolonged-release (OXN PR) doses adjusted only as necessary for ongoing analgesic titration at clinician discretion. At the end of the main study phase ( week 5) patients will move into the continuation phase. In the continuation study phase, patients originally in ARM 2 (Oxy PR) of the main study phase may be switched to receive ARM 1 treatment (OXN PR), and patients originally in ARM 1 (OXN PR) of the main study phase may be switched to receive ARM 2 treatment (Oxy PR) provided they are still able to swallow study medication, able to complete PRO tools and willing to switch medications. The continuation study will run for a further 6 weeks, with scheduled assessments occurring at 2-week intervals. Overall duration of administration is 11 weeks. Adherence of drug administration will be recorded at scheduled assessments. A trial drug medication list will be completed by recording number of pills dispensed and number of pills returned. It is anticipated it will take approximately 12 months to accrue 96 patients. The duration of the study will be 18 months. The administration of both medications will be the same, with instructions according to product information: Tablets will be taken every 12 hours regularly (twice daily), differing doses as prescribed per patient.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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)
Outcome results
None listed