NCT06863636

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

Efficacy and Safety Study of the Fixed-dose Combination of Celecoxib/Acetaminophen Compared to Celecoxib for the Treatment of Pain in Patients Diagnosed With Osteoarthritis in Acute Exacerbation

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Researchers will evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain in patients with osteoarthritis experiencing an acute exacerbation over a 6-week follow-up period. Adverse events related to the study interventions will be recorded throughout the follow-up phase. Participants will: Be randomized into one of three intervention groups (A, B, or C). Attend five scheduled clinic visits (Day 0, and Weeks 1, 2, 4, and 6 of follow-up). Be permitted to take 500 mg of naproxen as rescue medication, if needed, with prior authorization from the principal investigator.

Conditions

• Joint Pain
• Knee Osteoarthritis
• Hip Osteoarthritis

Interventions

Type	Name	Description
DRUG	Celecoxib + Acetaminohen	One tablet of 200 mg / 200 mg a day
DRUG	Celecoxi + Acetaminophen	One tablet of 200 mg / 500 mg a day
DRUG	Celecoxib	One capsule of 200 mg a day

Timeline

• Start date: 2024-09-09
• Primary completion: 2025-10-30
• Completion: 2025-11-30
• First posted: 2025-03-07
• Last updated: 2025-04-04

Locations

1 site across 1 country: Mexico