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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
Once a day for 60 days
Once a day for 60 days.
Grupo Médico ASSET, S.C.
Mexico City, Mexico City, Mexico
RM Pharma Specialists S.A. de C.V.
Mexico City, Mexico City, Mexico
Ainpad, S.C.
Morelia, Michoacán, Mexico
Hospital Centro Quirúrgico Nogalar, S.A. de C.V.
Monterrey, Nuevo León, Mexico
Pain intensity change
Pain intensity change measured by 100 mm - Visual Analogue Scale. A reduction of 20 mm or higher means a clinically relevant outcome.
Time frame: At 60 days from baseline
Osteoarthritis index change
Western Ontario and McMaster Universities Arthritis Index (WOMAC) 1. Pain (0-20 points) 2. Stiffness (0-8 points) 3. Functional capacity (0-68 points) Lower scores at the end of the intervention mean a better outcome.
Time frame: At 60 days from baseline
Use of rescue medication
Proportion of patients need to use rescue medication.
Time frame: At 60 days from baseline.
Quality of Life
Quality of Life will be measured using the Short Form-12 Health Survey (SF-12). SF-12 health survey, which yields two norm-based summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each score is standardized to a general population mean of 50 (SD = 10), where higher scores indicate better health-related quality of life."
Time frame: At 60 days from baseline.
Safety and tolerability
Proportion of patients experienced at least one adverse event.
Time frame: At 60 days from informed consent sign.
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