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

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.