NCT06863662

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

Efficacy and Safety of the Fixed-Dose Combination of Etoricoxib / Tizanidine Versus Etoricoxib in the Treatment of Patients With Acute Low Back Pain Associated to Muscle Spasm

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Researchers will compare the efficacy of a fixed-dose combination of etoricoxib and tizanidine versus etoricoxib alone in the treatment of acute low back pain associated with muscle spasms. Efficacy will be assessed by evaluating the average change in pain among patients who report improvement over the 7-day follow-up period. Adverse events related to the interventions will be recorded throughout the study. Participants will: * Be randomized into one of two intervention groups (Group A or Group B). * Attend three in-person clinic visits: Day 0 (baseline), Day 3, and Day 7 of follow-up. * Receive follow-up phone calls on Days 1 and 5. * Be allowed to take 500 mg of acetaminophen as rescue medication if needed, with prior authorization from the Principal Investigator.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-18
• Primary completion: 2025-09-26
• Completion: 2025-12-01
• First posted: 2025-03-07
• Last updated: 2026-01-09

Locations

1 site across 1 country: Mexico