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

NCT06863636 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Isabel E Rucker-Joerg, MD · Clinical Research Institute S.C.

  • Ivonne A Torres-Quiroz, MD · Unidad de Medicina Especializada SMA

  • Adelfia Urenda-Quezada, MD · Servicios Avanzados de Investigación Médica Mediadvance, S.C.

  • Martha V Chavira-Flores, MD · Consultorio Médico "Dr. Rodrigo Suárez Otero"

  • Rodrigo Suarez-Otero, MD · IMACEN S.A. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2025-10-30
Completion
2025-11-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863636 on ClinicalTrials.gov