E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058019 |
E.1.2 | Term | Cancer pain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Determine the pharmacogenetic features of patients who require cancer pain control. |
|
E.2.2 | Secondary objectives of the trial |
Assess safety of oxicodone in patient who require cancer pain control. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 < 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). |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |