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Efficacy and Safety of Etoricoxib/Cyanocobalamin Versus Etoricoxib for Acute Low Back Pain

NCT06517823 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-11-27

No results posted yet for this study

Summary

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in Patients With Acute Low Back Pain

Conditions

  • Acute Low-back Pain

Interventions

DRUG

Etoricoxib + Cyanocobalamin fixed dose

One tablet of 90 mg / 0.50 mg a day

DRUG

Etoricoxib fixed dose

One pill of 90 mg a day

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Ricardo Choza-Romero, MD · Centro de Atención e Investigación Clínica S.C.

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

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

  • Jesus H Mendoza-Ramírez, MD · Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-26
Primary Completion
2024-10-04
Completion
2024-10-11

Countries

  • Mexico

Study Locations

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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 NCT06517823 on ClinicalTrials.gov