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

Launched by LABORATORIOS SILANES S.A. DE C.V. · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a combination treatment using celecoxib and acetaminophen compared to celecoxib alone for managing joint pain in people with osteoarthritis who are experiencing a flare-up of their symptoms. Osteoarthritis is a condition that causes pain and stiffness in the joints, and this trial aims to find out if the combination of these two medications can provide better relief for patients suffering from moderate to severe pain in their knees or hips.

To be eligible for the trial, participants must be adults diagnosed with knee or hip osteoarthritis and experiencing significant pain for no more than three weeks. They should also agree to use contraception during the study if they are capable of becoming pregnant. Participants can expect to receive either the combination treatment or celecoxib alone, and their progress will be monitored over time. It's important to note that certain medical conditions and recent treatments may exclude individuals from participating, so potential participants should discuss their medical history with their doctor to see if they qualify.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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.
• Exclusion Criteria:
• • 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.
• • 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.