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 range18 Years – 65 Years

SexALL

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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.
✓. 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

What they're measuring

Pain intensity change

Timeframe: At 60 days from baseline

Trial details

NCT IDNCT07549386

SponsorLaboratorios Liomont

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-27

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