Actively Recruiting
Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation
Led by Laboratorios Silanes S.A. de C.V. · Updated on 2025-04-04
231
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate in the study and provides written informed consent.
- Prior diagnosis of knee or hip osteoarthritis based on clinical criteria (American College of Rheumatology criteria).
- Pain in the affected joint with exacerbation lasting no more than 3 weeks.
- Reports moderate to severe pain intensity (Visual Analog Scale 64; 40 mm).
- Women of childbearing potential agree to use at least one accepted contraceptive method during the study.
- Women not of childbearing potential meet criteria such as postmenopause or specified surgical history.
- Male subjects agree to use a male condom as contraception during the study.
- Investigator deems the subject suitable for treatment with the study drug and potential clinical benefit.
You will not qualify if you...
- Allergy or intolerance to the study drug or its components.
- Participation in another investigational study within the last two weeks.
- Employment or relationship with the research center or sponsor that could bias the study.
- Medical conditions preventing outpatient management as evaluated by the investigator.
- History of advanced, severe, progressive, or unstable diseases affecting safety or assessment.
- Medical contraindications to the study drug.
- Allergy to NSAIDs, acetaminophen, or formulation components.
- Significant gastrointestinal disorders or bleeding.
- Opioid treatment within the last five days.
- History of treatment failure with COX-2 inhibitors.
- Chronic somatic pain unrelated to osteoarthritis.
- Alcohol or drug abuse within the past year.
- NSAID treatment within 72 hours before consent (except cardioprotective aspirin).
- Arthroscopy, viscosupplementation, or intra-articular steroids in last three months.
- Surgery on affected joint within last six months.
- Major trauma to the affected joint within last three weeks.
- Chronic liver failure.
- Acute or severe renal failure.
- Significant coagulation disorders or current anticoagulant use.
- Active cancer (except basal cell carcinoma), severe illness with poor prognosis, or severe mental illness.
- Symptoms or recent contact related to COVID-19.
- Positive pregnancy test, pregnant or breastfeeding women, or planning pregnancy during the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Actively Recruiting
Research Team
J
Jorge A González, PhD
CONTACT
Y
Yulia Romero-Antonio, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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