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Joint PainPhase 3PRECEDENTNCT06863636

Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation

A Phase 3 study testing Celecoxib + Acetaminophen and Celecoxib in people with Joint Pain and Knee Osteoarthritis, run by Laboratorios Silanes S.A. de C.V. at 1 site 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

This is a Phase III, longitudinal, multicenter, randomized, double-blind clinical trial designed to evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain associated with acute exacerbations of osteoarthritis. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Celecoxib + Acetaminophen and Celecoxib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
1 siteMexico
Study dates
9 Sep 2024to 30 Nov 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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily agrees to participate in the study and provides written informed consent.
  • Prior diagnosis of knee or hip osteoarthritis based on clinical criteria (according to the American College of Rheumatology (ACR) criteria described in Annex 5).
  • Pain in the affected joint with exacerbation lasting no more than 3 weeks.
  • Patient reports moderate to severe pain intensity (VAS ≥ 40 mm).
  • For women of childbearing potential (a woman is considered fertile after menarche and until postmenopause unless permanently sterile), they must agree to use at least ONE of the following contraceptive methods during the study:
  • Barrier methods: diaphragm, cervical cap, male condom, female condom, spermicide foam, sponge, or film.
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  • Hormonal methods: combined oral contraceptives, injectable contraceptives, subdermal implant, contraceptive patch.
  • Intrauterine device (IUD): copper or silver IUD, Levonorgestrel intrauterine system (IUS), and/or combinations of the above as deemed acceptable by the physician.
  • Women are considered not of childbearing potential if they meet at least ONE of the following criteria:
  • Postmenopausal. Premenopausal woman with at least ONE of the following: hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
  • Male subjects must agree to use a male condom as a contraceptive method during the study.
  • At the discretion of the Principal Investigator (PI) or treating physician, the subject has an indication for treatment with the investigational product and may derive clinical benefit from it.

Who cannot join

  • Intolerance or allergy to the investigational product or any of its components (as reported in the medical history and patient interview).
  • Participation in another clinical study involving an investigational treatment or participation in one within the last two weeks prior to the study start.
  • Potential study bias due to employment or relationship with the research center, sponsor, or being part of a vulnerable population.
  • Medical conditions affecting prognosis that prevent outpatient management, to be evaluated by the Principal Investigator for subject inclusion relevance.
  • History of advanced, severe, progressive, or unstable disease of any kind that may interfere with efficacy and safety assessments or pose a special risk to the patient.
  • Medical contraindication to the investigational product.
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  • History of allergic reaction to NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), Acetaminophen, or known hypersensitivity to any formulation components.
  • Significant gastrointestinal disorders, such as gastric ulcers, Crohn's disease, ulcerative colitis, or gastrointestinal bleeding.
  • Prior opioid treatment within the last five days, as reported in the medical history.
  • History of treatment failure with COX-2 selective inhibitors, as documented in the medical history.
  • History of chronic somatic pain unrelated to knee or hip osteoarthritis (e.g., fibromyalgia, metastatic disease, or Paget's disease).
  • History of alcohol or drug abuse within the past year.
  • Current treatment with NSAIDs, including COX-2 inhibitors, within the last 72 hours before signing informed consent (except for aspirin used for cardioprotective purposes).
  • History of arthroscopy, viscosupplementation, or intra-articular steroid use in the last three months.
  • Previous surgery on the affected joint within the last six months.
  • Major trauma in the affected joint within the last three weeks.
  • History of chronic liver failure (Child-Pugh A, B, or C).
  • History of acute or severe renal failure (glomerular filtration rate <30 ml/min/1.73 m²), as reported in the medical history.
  • Significant coagulation disorders (e.g., Von Willebrand disease, hemophilia, vitamin K deficiency) or current use of anticoagulants.
  • Oncologic patients (except basal cell carcinoma) or those with severe illnesses that, according to the investigator, have a poor prognosis or a life expectancy of less than one year, including severe mental illness.
  • Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough, dyspnea) and/or contact within the last 14 days with a suspected or confirmed COVID-19 patient.
  • Positive pregnancy test, pregnant women, those currently breastfeeding, or those planning pregnancy during the study period.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Laboratorio Silanes, S.A. de C.V.

    Mexico City, Mexico City, 11000

Other trials in Mexico

About this study

Official title: Efficacy and Safety Study of the Fixed-dose Combination of Celecoxib/Acetaminophen Compared to Celecoxib for the Treatment of Pain in Patients Diagnosed With Osteoarthritis in Acute Exacerbation

This is a Phase III, longitudinal, multicenter, randomized, double-blind clinical trial designed to evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain associated with acute exacerbations of osteoarthritis.

Read the detailed description

Researchers will evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain in patients with osteoarthritis experiencing an acute exacerbation over a 6-week follow-up period. Adverse events related to the study interventions will be recorded throughout the follow-up phase.

Participants will:

Be randomized into one of three intervention groups (A, B, or C).

Attend five scheduled clinic visits (Day 0, and Weeks 1, 2, 4, and 6 of follow-up).

Be permitted to take 500 mg of naproxen as rescue medication, if needed, with prior authorization from the principal investigator.

Being tested
Celecoxib + Acetaminophen, Celecoxib
Keywords
Joint pain, Knee Osteoarthritis, Hip Osteoarthritis, Acute pain
Medical subject headings
Arthralgia, Osteoarthritis, Knee, Osteoarthritis, Hip, Acute Pain

What participants receive

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

  • Celecoxib + AcetaminophenDrug

    Also called Cele + Ace

    One tablet of 200 mg / 200 mg a day

  • Celecoxib + AcetaminophenDrug

    Also called Cele + Ace

    One tablet of 200 mg / 500 mg a day

  • CelecoxibDrug

    Also called Cele

    One capsule of 200 mg a day

Study groups in NCT06863636
Study groupRoleWhat they receive
Celecoxib+AcetaminophenExperimentalAdministered orally, 1 tablet a day during 6 weeks
Receives: Drug: Celecoxib + Acetaminophen
Celecoxib + AcetaminophenExperimentalAdministered orally, 1 tablet a day during 6 weeks
Receives: Drug: Celecoxib + Acetaminophen
CelecoxibActive comparatorAdministered orally, 1 capsule a day during 6 weeks
Receives: Drug: Celecoxib

What is being measured

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

  1. Comparison of the proportion of patients in each treatment group who, based on the baseline assessment, achieved a response according to the OMERACT-OARSI criteria at Weeks 1, 2, 4, and 6 of follow-up.

    OMERACT (Outcome Measures in Rheumatology) and OARSI (Osteoarthritis Research Society International) jointly developed a core outcome set (COS) for clinical trials in hip and knee osteoarthritis. This COS includes four key domains that should be assessed in all trials: pain, physical function, patient global assessment, and- for studies lasting one year or more-joint imaging. In this study, patients will be evaluated by the researcher at follow-up visits occurring at Weeks 1, 2, 4, and 6.

    Measured: 6 weeks

  2. Number of participants Number of participants reporting treatment-related adverse events, as recorded in the patient diary.treatment-related adverse events through the patient's diary record.

    To describe the frequency, intensity, and causality of adverse events occurring during the clinical trial, stratified by treatment group. Adverse events will be documented by participants in their patient diaries. Each reported event will be monitored and followed up at the discretion of the investigator.

    Measured: 6 weeks

Secondary outcomes (4)

  1. To analyze the mean change in pain scores, as measured by the WOMAC questionnaire, at Weeks 1, 2, 4, and 6 compared to baseline, by treatment group.

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a disease-specific questionnaire designed to assess physical function, pain, and stiffness in individuals with hip or knee osteoarthritis, based on their experiences over the past 48 hours. In this study, patients will be assessed by the investigator at Weeks 1, 2, 4, and 6 of follow-up.

    Measured: 6 weeks

  2. To analyze the mean change in pain intensity, as measured by the Visual Analog Scale (VAS), at Weeks 1, 2, 4, and 6 compared to baseline, stratified by treatment group.

    The Visual Analog Scale (VAS) for pain is a straight line where one end represents no pain and the other represents the worst pain imaginable. The investigator will administer the VAS at each visit to assess the patient's pain intensity. At the end of the clinical trial, the percentage change in pain scores will be calculated and compared across treatment groups.

    Measured: 6 weeks

  3. Comparison of the proportion of subjects in each treatment group who achieve a reduction of ≥30% in pain intensity, as measured by the Visual Analog Scale (VAS), at Weeks 1, 2, 4, and 6 compared to baseline.

    The Visual Analog Scale (VAS) for pain is a unidimensional measurement instrument consisting of a straight line anchored by descriptors, with one end indicating "no pain" and the other representing "the worst pain imaginable." The investigator will administer the VAS at each study visit to evaluate changes in pain intensity. The proportion of patients achieving a pain reduction of more than 30% from baseline will be documented and compared among treatment groups at Weeks 1, 2, 4, and 6.

    Measured: 6 weeks

  4. To analyze the difference in SF-36 quality of life questionnaire scores at six weeks after the initiation of the intervention, compared to baseline, by treatment group.

    The Short Form-36 (SF-36) is a generic health survey comprising 36 items designed to measure self-reported Health-Related Quality of Life (HRQoL). It evaluates multiple domains of physical and mental health and generates summary scores for both physical and mental components. In this study, the SF-36 questionnaire will be administered to each patient at baseline and again at Week 6 of follow-up.

    Measured: 6 weeks

Timeline

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

  1. First posted7 Mar 2025
  2. Study start9 Sep 2024
  3. Primary completion30 Oct 2025
  4. Study completion30 Nov 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
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06863636
Sponsor's protocol ID
SIL-30221-III-23(1)
Acronym
PRECEDENT
Status last verified
Oct 2026
First submitted
3 Mar 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ebrahimzadeh MH, Makhmalbaf H, Birjandinejad A, Keshtan FG, Hoseini HA, Mazloumi SM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Persian Speaking Patients with Knee Osteoarthritis. Arch Bone Jt Surg. 2014 Mar;2(1):57-62. Epub 2014 Mar 15.

    PubMed 25207315

  • Puljak L, Marin A, Vrdoljak D, Markotic F, Utrobicic A, Tugwell P. Celecoxib for osteoarthritis. Cochrane Database Syst Rev. 2017 May 22;5(5):CD009865. doi: 10.1002/14651858.CD009865.pub2.

    PubMed 28530031

  • Krieckaert CL, van Tubergen A, Gehin JE, Hernandez-Breijo B, Le Meledo G, Balsa A, Bohm P, Cucnik S, Elkayam O, Goll GL, Hooijberg F, Jani M, Kiely PD, McCarthy N, Mulleman D, Navarro-Compan V, Payne K, Perry ME, Plasencia-Rodriguez C, Stones SR, Syversen SW, de Vries A, Ward KM, Wolbink G, Isaacs JD. EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases. Ann Rheum Dis. 2023 Jan;82(1):65-73. doi: 10.1136/annrheumdis-2022-222155. Epub 2022 May 12.

    PubMed 35551063

  • Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.

    PubMed 22563589

  • Busse JW, Bartlett SJ, Dougados M, Johnston BC, Guyatt GH, Kirwan JR, Kwoh K, Maxwell LJ, Moore A, Singh JA, Stevens R, Strand V, Suarez-Almazor ME, Tugwell P, Wells GA. Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop. J Rheumatol. 2015 Oct;42(10):1962-1970. doi: 10.3899/jrheum.141440. Epub 2015 May 15.

    PubMed 25979719

  • Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.

    PubMed 31908163

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celecoxib + Acetaminophen and Celecoxib in people with Joint Pain and Knee Osteoarthritis, run by Laboratorios Silanes S.A. de C.V. at 1 site 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 12 inclusion and 22 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Comparison of the proportion of patients in each treatment group who, based on the baseline assessment, achieved a response according to the OMERACT-OARSI criteria at Weeks 1, 2, 4, and 6 of follow-up. (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT06863636, which also lists 6 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 23 Oct 2026.

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