chronic cancer pain R52.2
Conditions
Interventions
Group 1: once daily administration of Test Product Oxycodone HCl XL (and additionally Placebo for blinding as the Reference Product is given twice daily)
Group 2: twice daily administration of the Re
Sponsors
Develco Pharma Schweiz AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Caucasian male and female patients >18 years of age with chronic cancer or non-cancer pain. 2. Patients with predominantly non-neuropathic pain (assessed by e.g. the DN4 Neuropathic Pain Diagnostic Questionaire). 3. Patients requiring continuous oral opioid therapy with at least 40 mg oxycodone per day (or equivalent). 4. Adequate analgesia (mean "current" pain intensity per day =40 mm on VAS) prior to randomisation for at least three consecutive days. 5. Stable analgesic requirements prior to randomisation for at least three days (stable maintenance dose of oxycodone; requirement of at least 40 mg mg oxycodone per day; =2 doses of rescue medication per day), tolerable AEs). 6. ECOG (Eastern Cooperative Oncology Group) performance status <3. 7. Life expectancy of at least 3 months 8. Female patients of childbearing potential agree to undergo pregnancy tests. 9. Willingness to undergo a pre-study physical examination and pre- and post-study laboratory investigations. 10. Ability to comprehend and willingness to sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to oxycodone or any of the excipients of the study drugs. 2.Patients requiring more than 120 mg oxycodone per day (or equivalent). 3.Surgery within 1 month prior to study start and/or anticipated or scheduled surgical intervention during the study. 4.Intravenous chemotherapy and/or radiotherapy for pain alleviation and/or neural blockade within 2 weeks prior to study start and/or anticipated and/or scheduled during the course of the study. 5.Known or suspected clinically significant respiratory depression, hypoxia, hypercapnia, or decrease in respiratory reserve. 6.Known or suspected severe obstructive pulmonary disease, acute or severe bronchial asthma, or cor pulmonale. 7.Known or suspected significant hepatic impairment (hepatic transaminases >3 times the upper limit of normal). 8.Known or suspected severe renal impairment (CRCL <30 ml/min) or patients with renal failure who are on any form of dialysis. 9.Known or suspected significant circulatory disturbance, hypotension, or circulatory shock. 10.Known or suspected clinically relevant endocrine disorder, such as myxoedema, not adequately treated hypothyroidism or adrenocortical insufficiency (e.g. Addison's disease) 11.Known or suspected paralytic ileus, significant impairment of bowel motility severe enough to potentially result in ileus. 12.Known or suspected acute or chronic pancreatitis or biliary tract disease. 13.Any gastro-intestinal pathology or surgery or intractable vomiting likely to significantly influence drug absorption. 14.Inability to swallow the study drugs whole (e.g. due to dysphagia). 15.Known or suspected significant prostatic hypertrophy or urethral stricture severe enough to potentially result in urinary retention. 16.Known or suspected CNS depression (signs/symptoms: decreased vital signs, impaired thinking and perception, slurred speech, slowed reflexes, fatigue, decreased consciousness), coma, or convulsive disorder. 17.Known or suspected elevation of intracranial pressure. 18.Known or suspected acute alcoholism, delirium tremens, or toxic psychosis. 19.History of drug addiction or drug seeking behaviour. 20.Concomitant treatment with MAO inhibitors. 21.Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to practice adequate contraceptive measures. Reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence. 22.Any other condition of the patient that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s compliance or adherence to protocol requirements. 23.Previous enrolment in this study or participation in any other drug investigational trial within the past 30 days (or five half-lives whichever is longer) prior to enrolment. 24.Persons suspected to be at risk of suicide. 25.Persons who are not suitable for inclusion in the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to demonstrate that once daily administration of Oxycodone HCl XL tablets is at least as effective as twice daily administration of Oxygesic tablets at the same daily dosage. The primary efficacy endpoint is defined as overall "current" pain intensity (PI) on 0 - 100 mm VAS (mean "current" PI of the last 5 days of each treatment period). Pain intensity on 0 - 100 mm VAS at predefined time points will be collected through patient diaries. Mean "current" PI of the last 5 days of each tratment period will be analysed by means of an analysis of variance (ANOVA)). Non-inferiority of Oxycodone HCl XL tablets for once daily dosing will be concluded if the upper limit of the two-sided 95% confidence interval of the treatment difference between the test product and Oxygesic tablets does not exceed 12 mm in the overall "current" pain intensity (PI) on 0 - 100 mm VAS (mean "current" PI of the last 5 days of each treatment period). | — |
Secondary
| Measure | Time frame |
|---|---|
| - In the case of non-inferiority, to demonstarte that once daily administration of Oxycodone HCl XL tablets is more effective (superior) as twice daily administration of Oxygesic tablets at the same daily dosage - to assess the safety and tolerability of once daily administration of Oxycodone HCl XL tablets in comparison with twice daily administration of Oxygesic tablets - to investigate the oxycodone plasma concentrations during treatment with once daily administration of Oxycodone HCl XL tablets in comparison with twice daily administration of Oxygesic tablets (in a subset of maximum 20 patients) | — |
Countries
Germany, Poland
Contacts
Public ContactMartina Maritz
Develco Pharma Schweiz AG
Outcome results
None listed