Efficacy and Safety of Etoricoxib+Diacerein in Osteoarthritis. (NCT07549386) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Etoricoxib+Diacerein in Osteoarthritis.
Mexico123 participantsStarted 2024-05-24
Plain-language summary
The goal of this clinical trial is to learn if fixed-dose combination etoricoxib 90 mg + diacerein 50 mg capsule works to treat knee/hip osteoarthritis-associated pain in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:
Does etoricoxib+diacerein reduce pain intensity as per WOMAC scale after 60 days? What medical problems do participants have when taking etoricoxib 90 mg+diacerein 50 mg capsule for 60 days? Researchers will compare the test drug etoricoxib 90 mg+diacerein 50 mg capsule to an active comparator (meloxicam 15 mg + diacereina 50 mg) to see if drug ABC works to treat pain in patients with osteoarthritis.
Participants will:
Take drug the test or comparator drugs every day for 60 days. Visit the clinic once a month for health and outcomes follow-up. Keep a diary of their symptoms, pain intensity, WOMAC scale, adverse events, rescue medication use, other used drugs, and treatment adherence.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult men and women (≥ 18 and ≤ 65 years of age).
. Patients who agree to participate in the study by signing the informed consent form.
. Patients with a clinical diagnosis of knee or hip OA according to the American College of Rheumatology criteria with radiographic evidence of OA (K-L score ≥2) in the index joint (defined as the joint with OA being evaluated in this study).
. A joint previously treated by joint replacement surgery cannot be considered an index joint.
. A joint surgically intervened within the previous year cannot be considered an index joint.
. If a patient has a K-L score of ≥2 in more than one joint (knees or hip), the index joint will be the joint with the highest WOMAC pain subscore.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If two or more of the patient's joints (knees or hip) have a K-L score of ≥2 and the same WOMAC pain subscore, the index joint will be the joint with the highest K-L score.
. If two or more joints (knees or hip) have a K-L score of ≥2, the same WOMAC pain subscore, and the same K-L score, the investigator may choose one of these joints as the index joint based on medical judgment.
Exclusion criteria
. Patients with allergy or hypersensitivity to the study medications (including the rescue medication) or to any of their excipients.
. Patients with a body mass index ≥ 39.
. Patients with a history of rapidly progressive hip OA.
. Patients with a history of inflammatory joint disease other than OA (e.g., rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudogout, acute gout, joint infections) or seronegative spondyloarthropathy, Paget's disease of the spine, pelvis, or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, spinal cord tumors or infections, or renal osteodystrophy.
. History of arthropathy (osteonecrosis, insufficiency fracture of subchondral bone, rapidly progressive osteoarthritis type 1 or type 2), neuropathic joint arthropathy, hip dislocation, knee dislocation, extensive subchondral cysts, significant bone collapse, significant loss of bone mass, or pathological fractures.
. Scheduled joint replacement surgery to be performed during the study period, or arthroscopic procedures within 6 months prior to study initiation.
. Trauma to the index joint within 30 days prior to the screening visit.
. Use of systemic corticosteroids within 30 days prior to the screening visit or intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit.