Treatment of Chronic Pain From Osteoarthritis
Chronic Pain
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring osteoarthritis, pain, opioids
Eligibility Criteria
Inclusion Criteria:
- Subjects over the age of 60 years old
- Individuals with a primary diagnosis of osteoarthritis
- Subject that are able to understand the purpose of the study and that have signed a written informed consent
- Subjects that are able to take prescribed therapies, understand and complete the questionnaires and forms
Exclusion Criteria:
- Subject with history of hypersensitivity to oxycodone, naloxone , codeine , acetaminophen, ibuprofen, and the other ingredients in the formulations studied
- Subjects with known structural alterations in the gastrointestinal tract
- Subjects with secondary osteoarthritis
- Subjects with history of abuse of alcohol and / or drugs
- Subjects with history of abuse opioids.
- Patients suffering from rheumatoid arthritis
- Patients with evidence of medical or surgical unstable
- Patients with current or previous history of epilepsy
- Patients treated with anti-depressive action on the central nervous system which in the opinion of the investigator may result in additive effects with the drugs under study.
- Subjects with renal and / or hepatic impairment severe
- Subjects with a history of depression or other psychiatric condition that, in the opinion of the investigator might interfere with the study participation
- Individuals with cognitive impairment
Sites / Locations
- Azienda Ospedaliera della Provincia di Pavia - Ospedale "Carlo Mira" - U.O. Medicina Interna - Servizio di Anestesia e Rianimazione - Ambulatorio di Terapia del dolore
- Azienda Istituti Ospitalieri di Cremona, Presidio Ospedaliero di Cremona - U.O. di Anestesia, Analgesia e Medicina Perioperatoria
- Azienda Ospedaliera della provincia di Lodi Dipartimento emergenza urgenza
- Azienda Ospedaliera Istituto Ortopedico Gaetano Pini - U.O.C. Anestesia e Rianimazione
- Azienda Ospedaliera della Provincia di Pavia - Ospedale Asilo Vittoria di Mortara - U.O. di Pneumotisiologia
- Clinica San Carlo - Casa di Cura Polispecialistica S.p.A. - Unità di Terapia del Dolore
- Fondazione IRCCS Policlinico San Matteo
- Azienda Servizi alla Persona, ASP, "II.AA.RR." - Istituto di Riabilitazione "Santa Margherita" - Struttura Complessa di Riabilitazione
- Fondazione Salvatore Maugeri - sede di Via Boezio - UO Cure Palliative e Terapia del Dolore
- IRCCS Istituto Clinico "Humanitas" - Anestesia, Day Hospital chirurgico - Chronic Pain Service
- Dipartimento Integrato di Lungassistenza Anziani - ASL TO1
- Ospedale di circolo Fondazione Macchi - SSD Anestesia Day Surgery
- Azienda Ospedaliera della Provincia di Pavia - Ospedale Civile di Vigevano - Servizio di Anestesia e Rianimazione
- Azienda Ospedaliera della Provincia di Pavia - Ospedale Civile di Voghera- U.O. di Medicina Interna - U.O. di Riabilitazione specialistica
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Codeine/paracetamol
Oxycodone/Naloxone
The combination codeine/paracetamol,30 mg/500 mg,1 tablet every 8 hours, paracetamol 500 mg if NRS> 4, repeatable up to 3 times per day. At any stage of the study, patients treated with combination codeine/paracetamol in case of ineffectiveness (NRS> 4) despite maximal dosage (2 tablets every 8 hours) and/or side effect, will be subject to the opioid switch and will start equianalgesic therapy with oxycodone/naloxone combination.
Combination oxycodone /naloxone, 5 mg/2.5 mg, 1 tablet/day, paracetamol 500 mg if NRS> 4, repeatable up to 3 times per day.