Treatment of Chronic Pain From Osteoarthritis

• Status: Withdrawn
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo
• Treatments: Acetaminophen; Codeine; Naloxone; Oxycodone

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