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:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT00236366
Eligibility Criteria:
Inclusion Criteria:
* Patients with osteoarthritis (OA) of the hip or the knee (as defined by the American College of Rheumatology) and radiological evidence of OA from the target joint
* patients must be in need of and waiting for hip or knee replacement
* patients with chronic pain for longer than 3 months for \>=20 days/month
* patients with moderate to severe OA pain of the target joint (VAS score \>=50 on a scale of 0-100), whose pain was not adequately controlled with weak opioids, with or without non-opioid pain medication
* women must be postmenopausal or using adequate contraception, have a negative pregnancy test at study initiation, and not be breastfeeding.
Exclusion Criteria:
* Patients who had previously failed fentanyl therapy or had discontinued treatment due to adverse events
* known allergy or hypersensitivity to fentanyl or to the adhesives
* patients being treated for depression or epilepsy
* patients who received sedative hypnotics, anaesthetics and/or muscle relaxants in the week preceding the Run-In Period
* patients experiencing another type of continuous pain that stands out in comparison with OA pain
* patients with major trauma to the target joints, infection in these joints, or irreversible damage to these joints during the 6 months before the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
41 Years
Study:
NCT00236366
Study Brief:
Protocol Section:
NCT00236366