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Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm

NCT06863662 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-01-09

No results posted yet for this study

Summary

This is a Phase III, longitudinal, multicenter, randomized, double-blind clinical trial. The aim of the study is to evaluate the efficacy and safety of a fixed-dose combination of etoricoxib and tizanidine compared to etoricoxib alone in patients with acute low back pain associated with muscle spasms.

Conditions

  • Acute Low-back Pain
  • Muscle Spasm; Back Pain

Interventions

DRUG

Etoricoxib + Tizanidine fixed dose

One sachet with 120 mg / 4 mg, dissolved in 100 mL of water

DRUG

Etoricoxib fixed dose

One sachet with 120 mg, dissolved in 100 mL of water

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Lilia E Acevedo-Rojas, MD · Oaxaca Site Management Organization, S.C.

  • Mauricio Flores-Araujo, MD · Mérida/ Investigación Clínica

  • Salvador Perez-Jaime, MD · Centro de Investigación Médica Aguascalientes (CIMA)

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
2024-09-18
Primary Completion
2025-09-26
Completion
2025-12-01

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 NCT06863662 on ClinicalTrials.gov