RHEUMATOID ARTHRITIS MedDRA version: 6.1 Level: PT Classification code 10039073
Conditions
Interventions
Trade Name: DEPALGOS*20+325MG 28CPR RP
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OXICODONE DC.IT
CAS Number: 76-42-6
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
A.U.S.L. RIMINI
Eligibility
Sex/Gender
All
Inclusion criteria
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 . 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;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. | — |
Countries
Italy
Outcome results
None listed