Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT02032927
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
100 Years
Study:
NCT02032927
Study Brief:
Protocol Section:
NCT02032927