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Compares treatment options for Joint Pain
Official title Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation
ClinicalTrials.gov ID: NCT06863636
What this study is testing
What is Celecoxib + Acetaminohen?
Celecoxib + Acetaminohen is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for joint pain.
Also referred to as Cele + Ace.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- History of advanced, severe, progressive, or unstable disease of any kind that may interfere with how well it works and safety assessments or pose a...
- Medical contraindication to the investigational product.
See the full eligibility 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...
- 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.
- 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 how well it works 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.