None listed
Conditions
Interventions
Oxicodone Type of group
For patients treated with 1 to 5 tablets / capsules of a fixed combination of regular opioid / non-opioid doses, the initial dose of the patient should be 10 to 20 mg of extended release oxycodone every 12 hours. For patients treated with 6 to 9 tablets / capsules, 20 to 30 mg every 12 hours should be used at the initial dose. For patients treated with 10 to 12 tablets / capsules per day, it is suggested that the initial dose be 30 to 40 mg every 12 hours. The choice of the higher or lower dose
Sponsors
TECNOFARMA S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Adult male or female patients between 18 and 70 years of age with a diagnosis of cancer confirmed in histopathological form with chronic, moderate to severe cancer pain and who have had previous analgesic treatment failure with level 1 analgesics according to the scale of the WHO. Patients may be hospitalized or be in the outpatient department (the latter must qualify for 60% or more of the Kamofsky Scale just before carrying out the baseline studies • Patients who can swallow whole tablets (not chewed, divided or crushed). • Patients who accept and can sign an informed consent. • Patients with reason use, who respond appropriately, able to make a subjective assessment and to comply with scheduled visits during the study period. • Patients who know how to read and write and are able to keep a diary during their participation in the study. • Patients with chronic malignant pain of moderate to severe intensity, and whether the pain is somatic or nociceptive.
Exclusion criteria
Exclusion criteria: • Pregnant or lactating patients. • Patients who are really allergic to oxycodone or have a history of allergies or hypersensitivity to oxycodone or other opioids. This does not include patients who have experienced the common adverse effects of opioids (for example nausea, constipation, etc.) or patients whose participation in this study is contraindicated according to Appendix I • Patients scheduled for surgery (dental included) during the four-week study period. • Patients who have had a gastrostomy or colostomy. • Patients who have been treated with an antineoplastic (chemo or radiotherapy) in the 14 days prior to the baseline analysis or during the course of this study. • Patients with acute or severe bronchial asthmatic status. • Patients with a history of, or with active severe organ dysfunction; history of or suspected paralytic ileus; physical or psychological pathology or a laboratory diagnosis that could represent an increased risk for the patient due to exposure to the drug in this experimental study (see Appendix I) or that could alter the interpretation of this investigation. • Patients with severe respiratory depression. • Patients who are currently treated or treated with another experimental drug within 30 days prior to the start of the study. • Patients with a psychopathic or sociopathic background or any serious psychiatric illness. • Patients treated with an opioid analgesic at the beginning of the study, which can not be discontinued. (All opioid medications outside the study should be discontinued before the start of the study.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The overall acceptance of the treatment is assessed by the patient considering the intensity of the pain and the adverse effects. A rating scale is used as follows: 1 = Terrible 2 = Bad 3 = Acceptable 4 = Good 5 = Excellent Measure:Pain Intensity Timepoints:Week 1 and 2 of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Questionnaire on patient satisfaction - At the beginning, the patient is asked the following question: What is your level of satisfaction with the analgesic treatment you are now receiving for your pain? The patient will rate their degree of satisfaction with the previous analgesic to study in the following scale: 1 = very dissatisfied 2 = something unsatisfied 3 = uncertain 4 = somewhat satisfied 5 = very satisfied Measure:Patient satisfaction Timepoints:Week 1 and 2 of follow up | — |
Outcome results
None listed