Pharmacogenetic evaluation of oxicodone in patients. - ND
- Conditions
- Cancer chronic pain.MedDRA version: 9.1Level: LLTClassification code 10058019Term: Cancer pain
- Registration Number
- EUCTR2007-004267-22-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA PISANA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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 < 50 ml/min); d. Serious concomitant disease, including but not restricted to renal insufficiency, major cardiac disease (arrhythmias), edema, diastolic blood pressure > 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method