Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorLaboratorios Silanes S.A. de C.V.
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Celecoxib + Acetaminohen
- Celecoxi + Acetaminophen
- Celecoxib
Treatment groups
231 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov