Treatment of Chronic Pain From Osteoarthritis
WithdrawnPhase 4NCT02032927
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Osteoarthritis is a common joint disorder in the elder population.The current treatment options include both a non-pharmacological approach (physiokinesitherapy, diet) or if this fails, a pharmacological approach that relies in the first instance on drugs such as paracetamol, non-steroidal anti-inflammatory (including inhibitors of cyclo-oxygenase). However, the use of these drugs is limited, by the roof effect concerning analgesia, and by the potential side effects. When pharmacological treatments with non-opioid medications fail, and a moderate-to-severe pain reduces the quality of life of the patient, international guidelines suggest the use of opioid drugs.
Study details
- Official title
- A Comparative Study Between Two Pharmacological Associations Oxycodone/Naloxone And Codeine / Paracetamol In Treatment Of Moderate-Severe Chronic Pain Due To Osteoarthritis Of Knee And/Or Hip
- Conditions
- Interventions
- Drug: Codeine/paracetamol
- Drug: Oxycodone/naloxone
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Start date
- 2013-06
- Primary completion
- 2015-06
- Sex
- All
- Age range
- from 60 Years to 100 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 14
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02032927