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Pain ManagementPhase 3NCT07549386

Efficacy and Safety of Etoricoxib+Diacerein in Osteoarthritis.

A Phase 3 study testing Etoricoxib 90 mg + diacerein 50 mg and Meloxicam 15 mg + diacerein 50 mg in people with Pain Management and Osteoarthritis, run by Laboratorios Liomont at 4 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain Management, Osteoarthritis
What is being tested?
Etoricoxib 90 mg + diacerein 50 mg and Meloxicam 15 mg + diacerein 50 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
4 sitesMexico
Study dates
24 May 2024to 15 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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).
  • 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.
  • Current history of alcoholism and/or drug abuse.
  • 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.
  • Women with a positive pregnancy test at the time of screening or who are breastfeeding.

Trial locations and contacts

4 sites in 1 country.

Mexico4 sites

  • Grupo Médico ASSET, S.C.

    Mexico City, Mexico City, 03100

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

    Mexico City, Mexico City, 03100

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

    Monterrey, Nuevo León, 66484

  • Ainpad, S.C.

    Morelia, Michoacán, 58350

Other trials in Mexico

About this study

Official title: 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.

Read more

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.

Being tested
Etoricoxib 90 mg + diacerein 50 mg, Meloxicam 15 mg + diacerein 50 mg
Medical subject headings
Agnosia, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Etoricoxib 90 mg + diacerein 50 mgDrug

    Once a day for 60 days

  • Meloxicam 15 mg + diacerein 50 mgDrug

    Once a day for 60 days.

Study groups in NCT07549386
Study groupRoleWhat they receive
Etoricoxib 90 mg + diacerein 50 mgExperimentalOne capsule
Receives: Drug: Etoricoxib 90 mg + diacerein 50 mg
Meloxicam 15 mg + diacerein 50 mgActive comparatorOne capsule
Receives: Drug: Meloxicam 15 mg + diacerein 50 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 60 days from baseline

Secondary outcomes (4)

  1. 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.

    Measured: At 60 days from baseline

  2. Use of rescue medication

    Proportion of patients need to use rescue medication.

    Measured: At 60 days from baseline.

  3. 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."

    Measured: At 60 days from baseline.

  4. Safety and tolerability

    Proportion of patients experienced at least one adverse event.

    Measured: At 60 days from informed consent sign.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study start24 May 2024
  3. Primary completion27 Mar 2025
  4. Study completion15 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07549386
Sponsor's protocol ID
LT-12-17
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25889669

  • 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.

    PubMed 30863143

  • 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.

    PubMed 22870441

  • 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.

    PubMed 29309269

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etoricoxib 90 mg + diacerein 50 mg and Meloxicam 15 mg + diacerein 50 mg in people with Pain Management and Osteoarthritis, run by Laboratorios Liomont at 4 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity change (time frame: At 60 days from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07549386, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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