Advanced cancer patient with severe cancer pain MedDRA version: 6.1 Level: PT Classification code 10033371
Conditions
Interventions
Trade Name: Oxycontin 28cpr 10mg R.P.
Product Name: oxicodone
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxicodone
Current Sponsor code: INT 35/06
Concentration unit: mg milli
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following is the patient profile criteria Patients older than 18 years of age, patients with oncological referred pain within the 24 hours preceding the initial administration of treatment with an intensity of greater than or equal to 5 measured by the numerical scale NRS of 11 levels 0-10 , patients who did not take other analgesics or who only took NSAIDs and/or weak opioids either I or II on the WHO scale , patients have given their written consent, patients in the study have been given at least one month to live, patients are required to follow the treatment regiment for at least 2 weeks under clinical observation, patients with KPS greater than or equal to 40. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with one or more of the following criteria are not appropriate patients for this type of study Treatment with morphine, oxycodone, buprenorphine, fentanyl, or methadone in the 30 days leading up to the study. Patients whose medical history, based on the opinions of a physicians, is significant for intolerance to morphine or oxycodone Patients whose doctors have suggested they should add ex novo another analgesic adjuvant steroids, anticonvulsants, antidepressants Patients with severe renal impairment Patients with moderate to severe hepatic insufficiency Patients with dispnea or severe BPCO Patients who are not able to be treated taking oral medications as recommended by the WHO guidelines Patients who have a history of ongoing psychiatric illness Patients with cognitive deficit that cannot consent to the treatment and will not comply with the treatment protocol Patients with cerebral metastasis Patients who are either pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the tolerability profile of controlled release oxycodone to controlled release morphine during the first 14 days of administration for the treatment of moderate to severe chronic oncological pain.;Secondary Objective: The secondary objectives of the study are to compare the two above mentioned treatments in terms of efficacy in pain reduction, tolerability and efficacy in elderly patients age 70 years , tolerability and efficacy in patients with renal impairment creatininemia levels 1.2 mg/dl and 3 mg/dl .;Primary end point(s): The primary outcome variable is the dichotomous variable that indicates a worsening, in the first 14 days of treatment, of at least one of the following adverse effects nausea, vomiting, hallucinations, mental confusion, constipation, sedation, dry mouth, itching. The patient was defined to have deteriorated if, in respect to the base-line evaluation, he registered a worsening of at least 2 points of a scale of 0 to 10 for at least one of the symptoms considered and for at least one of the two weeks of treatment. For hallucinations the worsening is indicated by the presence of at least one episode during the two weeks of treatment. | — |
Countries
Italy
Outcome results
None listed