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

Recruiting Phase 3 Interventional Study
Joint Pain Knee Osteoarthritis Hip Osteoarthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
231 (estimated)
Sponsor
Laboratorios Silanes S.A. de C.V. · Industry
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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.

Trial Locations
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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 join…
Contacts

Jorge A González, PhD

5254883785

jogonzalez@silanes.com.mx

CONTACT

Yulia Romero-Antonio, B.S.

5254883785

yromero@silanes.com.mx

CONTACT