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 | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
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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 |
OBJECTIVES OF PHASE II PRIMARY to assess the efficacy of oxycodone/paracetamol rapid release in patients suffering moderate to severe chronic pain due to rheumatoid arthritis OBJECTIVES OF PHASE IIIB PRIMARY to assess the efficacy of anti-inflammatory non-steroidal drugs FANS and corticosteroid in comparison to oxycodone/paracetamol rapid release in patients suffering moderate to severe chronic pain due to rheumatoid arthritis |
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E.2.2 | Secondary objectives of the trial |
PHASE II to assess the tolerability of oxycodone/paracetamol rapid release in patients suffering moderate to severe chronic pain due to rheumatoid arthritis PHASE IIIB to assess the tolerability of the treatment with anti-inflammatory non-steroidal drugs FANS and corticosteroid in comparison to the treatment with oxycodone/paracetamol rapid release in patients suffering moderate to severe chronic pain due to rheumatoid arthritis |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
61623; Male or female patients at least 18 years or older 61623; Moderate to severe VAS 50 chronic pain suffering from more than 3 months of osteo-articular muscle origin 61623; Non-responsive to at least two lines of immunosuppressive therapy 61623; Blood analysis and ECG not earlier than 3 months before the begging of the study 61623; Subjects able to read, understand and sign the informed consent . |
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E.4 | Principal exclusion criteria |
61623; Subjects who partecipated in a clinical research study within the last 3 months 61623; Subjects not willing or not able to sign the informed consent 61623; Subjects who are already treated with biological drugs anti-TFN 61537; or antagonists of interleukin-1 receptor 61623; Subjects with acute abdomen or paralytic and/or mechanic ileus 61623; Subjects suffering depression of the SNC alteration of the level of vigilance , in particular those induced from drugs such as benzodiazepine or barbiturates, or uncontrolled epilepsy 61623; Subjects suffering acute alcoholism with or without delirium tremens 61623; Subjects with clinical signs and symptoms of endocranic hypertension 61623; Subjects suffering acute respiratory impairment and/or asthmatic crisis in existence; acute hepatitis serious hepatic or renal impairment 61623; Subjects under treatments with IMAO and tricycles antidepressants 61623; Subjects suffering prostate hypertrophy with urinary retention or generalised sepsis 61623; Female subjects who are pregnant or breast-feeding 61623; Subjects planning to have a surgical operation 61623; Subjects with known hypersensitivity to the drugs in study 61623; Other contraindications reported in the Technical Card SPC of the drugs of study 61623; Subjects with other conditions or diseases that would, in the opinion of the investigator, prevent participation in this study |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the safety and efficacy of oxycodone/paracetamol rapid release for the treatment of moderate to severe pain in patients suffering rheumatoid artritis. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |