Efficacy and Safety of Etoricoxib+Diacerein in Osteoarthritis.

NCT07549386 | Completed Phase 3

• 1 other identifier: LT-12-17
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pain Management; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Osteoarthritis index change

  At 60 days from baseline

• Use of rescue medication

  At 60 days from baseline.

• Quality of Life

  At 60 days from baseline.

• Safety and tolerability

  At 60 days from informed consent sign.

Study Arms (2)

Etoricoxib 90 mg + diacerein 50 mg

EXPERIMENTAL

One capsule

Drug: Etoricoxib 90 mg + diacerein 50 mg

Meloxicam 15 mg + diacerein 50 mg

ACTIVE COMPARATOR

One capsule

Drug: Meloxicam 15 mg + diacerein 50 mg

Interventions

Etoricoxib 90 mg + diacerein 50 mg DRUG

Once a day for 60 days

Etoricoxib 90 mg + diacerein 50 mg

Meloxicam 15 mg + diacerein 50 mg DRUG

Once a day for 60 days.

Meloxicam 15 mg + diacerein 50 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with moderate to severe pain in the index joint defined as a WOMAC pain subscore of ≥4.
• Patients who, in the investigator's medical judgment, can discontinue current analgesic medications and are willing to comply with the study requirements.

You may not qualify if:

• 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.
• Concomitant use of medications with laxative effects.
• 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.
• 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.
• History of peptic ulcer or gastrointestinal bleeding within 12 months prior to the screening visit and/or medical contraindication for the use of NSAIDs.
• Severe gastrointestinal disorders, including persistent diarrhea (≥3 bowel movements/24 hours).
• Renal insufficiency (serum creatinine ≥1.8 mg/dL or 2+ proteinuria on a test or a glomerular filtration rate \<30 mL/min).
• Liver enzyme levels (ALT, AST, GST) elevated ≥2.5 times the upper limit of normal at the time of screening.

Sponsors & Collaborators

• Laboratorios Liomont: lead
• EPIC Research CRO: collaborator

Study Sites (4)

Grupo Médico ASSET, S.C.

Mexico City, Mexico City, 03100, Mexico

Location

RM Pharma Specialists S.A. de C.V.

Mexico City, Mexico City, 03100, Mexico

Location

Ainpad, S.C.

Morelia, Michoacán, 58350, Mexico

Location

Hospital Centro Quirúrgico Nogalar, S.A. de C.V.

Monterrey, Nuevo León, 66484, Mexico

Location

Related Publications (4)

• 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.

  PMID: 25889669 BACKGROUND

• 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.

  PMID: 30863143 BACKGROUND

• 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.

  PMID: 22870441 BACKGROUND

• 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.

  PMID: 29309269 BACKGROUND

MeSH Terms

Conditions

Agnosia; Osteoarthritis

Interventions

Etoricoxib; diacerein; Meloxicam

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazines; Thiazoles; Azoles

Study Officials

• Livan Delgado Roche, Ph.D.

  Laboratorios Liomont

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 24, 2026
• Study Start: May 24, 2024
• Primary Completion: March 27, 2025
• Study Completion: October 15, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (4)