Cancer chronic pain. MedDRA version: 9.1 Level: LLT Classification code 10058019 Term: Cancer pain
Conditions
Interventions
Trade Name: OXYCONTIN
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patients of either sex aged 18-80 years; b. Chronic pain; c. Patients scheduled to receive oxycodon; d. Informed consent signed by the patient, relatives or legal representative. 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: a. Contraindications to oxycodone treatment; b. Previous/concomitant treatment with systemic drugs known to affect oxycodone absorption/distribution/excretion or to interact with oxycodone; c. Renal functional impairment (creatinine clearance 100 mmHg, hypertension, significant cardiovascular or pulmonary dysfunction in the previous 6 months, immunodeficiency syndromes (e.g. HIV, disease requiring immunosuppressive therapy); e. For sexually active female patients: absence of adequate contraceptive measures, pregnancy, breast feeding; f. Alcohol abuse (ethanol intake > 210 g for week within the previous 1 year, i.e. > 2 bottles of beer or > 3 glasses of wine per day).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the pharmacogenetic features of patients who require cancer pain control.;Secondary Objective: Assess safety of oxicodone in patient who require cancer pain control.;Primary end point(s): a. To evaluate the presence of polymorphisms of genes coding for enzymes involved in oxycodone metabolism and those coding for opioid receptors; in particular the following genes and related polymorphic variants will be investigated: CYP2D6, variants CYP2D6*4 (1846G>A), CYP2D6*6 (1707delT) e CYP2D6*10 (100C>T); CYP3A4, variants CYP3A4*1B(-290 G>A); CYP3A5, variants CYP3A5*3 (6986A>G); OPRM1 (mu opioid receptor), variants 118A>G e 802T>C; ABCG2, 421C>A (Gln141-Lys); ABCB1, 3435C>T, 2677G>T, 1236C>T. b. To correlate pharmacogenetic results and titration schedule of oxycodone. In particular, final daily dose and time to reach it will be considered. | — |
Countries
Italy
Outcome results
None listed