Efficacy and Safety of Etoricoxib+Diacerein in Osteoarthritis.

Efficacy and Safety of Etoricoxib 90 mg + Diacerein 50 mg Capsule Compared to Meloxicam 15 mg + Diacerein 50 mg in Patients With Knee and/or Hip Osteoarthritis: A Phase III, Controlled, Randomized, Double-blind, Multicenter Clinical Trial.

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 Overview

• Status: Completed
• Conditions: Osteoarthritis; Pain Management
• Intervention / Treatment: Drug: Etoricoxib 90 mg + diacerein 50 mg; Drug: Meloxicam 15 mg + diacerein 50 mg

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 03100
      • Grupo Médico ASSET, S.C.
    • Mexico City, Mexico City, Mexico, 03100
      • RM Pharma Specialists S.A. de C.V.
  • Michoacán
    • Morelia, Michoacán, Mexico, 58350
      • Ainpad, S.C.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66484
      • Hospital Centro Quirúrgico Nogalar, S.A. de C.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult men and women (≥ 18 and ≤ 65 years of age).
2. Patients who agree to participate in the study by signing the informed consent form.

3. 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).

   1. A joint previously treated by joint replacement surgery cannot be considered an index joint.
   2. A joint surgically intervened within the previous year cannot be considered an index joint.
   3. 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.
   4. 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.
   5. 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.
4. Patients with moderate to severe pain in the index joint defined as a WOMAC pain subscore of ≥4.
5. Patients who, in the investigator's medical judgment, can discontinue current analgesic medications and are willing to comply with the study requirements.

Exclusion Criteria:

1. Patients with allergy or hypersensitivity to the study medications (including the rescue medication) or to any of their excipients.
2. Patients with a body mass index ≥ 39.
3. Patients with a history of rapidly progressive hip OA.
4. 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.
5. 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.
6. Scheduled joint replacement surgery to be performed during the study period, or arthroscopic procedures within 6 months prior to study initiation.
7. Trauma to the index joint within 30 days prior to the screening visit.
8. 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.
9. Concomitant use of medications with laxative effects.
10. Continuous oral treatment (at least 90 days) with a SYSADOA medication (chondroitin sulfate, glucosamine sulfate, diacerein, or other) within 3 months before the start of the study.
11. Use of monoamine reuptake inhibitors, tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors for pain treatment within 4 weeks prior to the screening visit.
12. History of peptic ulcer or gastrointestinal bleeding within 12 months prior to the screening visit and/or medical contraindication for the use of NSAIDs.
13. Severe gastrointestinal disorders, including persistent diarrhea (≥3 bowel movements/24 hours).
14. Renal insufficiency (serum creatinine ≥1.8 mg/dL or 2+ proteinuria on a test or a glomerular filtration rate <30 mL/min).
15. Liver enzyme levels (ALT, AST, GST) elevated ≥2.5 times the upper limit of normal at the time of screening.
16. History or presence of cardiovascular diseases (e.g., second- or third-degree heart block, first-degree heart block with abnormal QRS or bifascicular block, history of uncontrolled arterial hypertension, congestive heart failure classified as NYHA stage II-IV, transient ischemic attack (TIA) or stroke within 12 months prior to the screening visit, or myocardial infarction or acute coronary syndromes or evidence of peripheral vascular insufficiency with claudication within 6 months prior to the screening visit).
17. History of other comorbidities that, in the investigator's judgment, could affect the subject's participation in the study, their safety, or the outcome of the study variables.
18. Current history of alcoholism and/or drug abuse.
19. Current participation in a clinical research study evaluating another investigational drug or having received another investigational product within 30 days prior to the screening visit.
20. Women with a positive pregnancy test at the time of screening or who are breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etoricoxib 90 mg + diacerein 50 mg; One capsule	Drug: Etoricoxib 90 mg + diacerein 50 mg; Once a day for 60 days
Active Comparator: Meloxicam 15 mg + diacerein 50 mg; One capsule	Drug: Meloxicam 15 mg + diacerein 50 mg; Once a day for 60 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 60 days from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteoarthritis index change	Western Ontario and McMaster Universities Arthritis Index (WOMAC); Pain (0-20 points); Stiffness (0-8 points); Functional capacity (0-68 points) Lower scores at the end of the intervention mean a better outcome.	At 60 days from baseline
Use of rescue medication	Proportion of patients need to use rescue medication.	At 60 days from baseline.
Safety and tolerability	Proportion of patients experienced at least one adverse event.	At 60 days from informed consent sign.
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."	At 60 days from baseline.

Collaborators and Investigators

• Sponsor: Laboratorios Liomont
• Collaborators: EPIC Research CRO
• Investigators: Study Director: Livan Delgado Roche, Ph.D., Laboratorios Liomont

Publications and helpful links

General Publications

• Martel-Pelletier J, Pelletier JP. Effects of diacerein at the molecular level in the osteoarthritis disease process. Ther Adv Musculoskelet Dis. 2010 Apr;2(2):95-104. doi: 10.1177/1759720X09359104.
• Cuomo A, Bimonte S, Forte CA, Botti G, Cascella M. Multimodal approaches and tailored therapies for pain management: the trolley analgesic model. J Pain Res. 2019 Feb 19;12:711-714. doi: 10.2147/JPR.S178910. eCollection 2019.
• Kongtharvonskul J, Anothaisintawee T, McEvoy M, Attia J, Woratanarat P, Thakkinstian A. Efficacy and safety of glucosamine, diacerein, and NSAIDs in osteoarthritis knee: a systematic review and network meta-analysis. Eur J Med Res. 2015 Mar 13;20(1):24. doi: 10.1186/s40001-015-0115-7.
• Lespasio MJ, Sultan AA, Piuzzi NS, Khlopas A, Husni ME, Muschler GF, Mont MA. Hip Osteoarthritis: A Primer. Perm J. 2018;22:17-084. doi: 10.7812/TPP/17-084.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Osteoarthritis; Agnosia; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Thiazines; Sulfones; Meloxicam; Etoricoxib; diacerein
• Other Study ID Numbers: LT-12-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No