Trial intelligence / Profile preview

Etoricoxib + Tizanidine vs Etoricoxib in acute low back pain with muscle spasm

NCT06863662Phase 3

Key facts

Status: Completed
Start: Sep 2024
Primary completion: Sep 2025
Countries: 1
Sponsor: Laboratorios Silanes
Modality: Small Molecules

Drugs: tizanidine
Conditions: acute low back pain

Overview

Phase 3, randomised, double-blind trial of tizanidine in acute low back pain (2 arms), sponsored by Laboratorios Silanes. Primary endpoints: Percentage change in pain intensity measured by Visual Analog Scale at 7 days and Number of participants reporting treatment-related adverse events at 7 days. Started Sep 2024; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Etoricoxib+Tizanidine
Fixed-dose combination of etoricoxib 120mg and tizanidine 4mg administered orally once daily for 7 days
Etoricoxib
Etoricoxib 120mg administered orally once daily for 7 days

Who it enrols

Adults with acute low back pain (≤6 weeks duration) associated with muscle spasm, moderate to severe pain (VAS ≥40mm), DN4 score <4, excluding patients with cardiovascular disease, liver/renal impairment, seizure disorders, chronic pain conditions, recent NSAID/opioid use, and active infections

Endpoints

Primary

Percentage change in pain intensity measured by Visual Analog Scale7 days
Number of participants reporting treatment-related adverse events7 days

Secondary

Percentage change in pain intensity measured by Visual Analog Scale compared between groups7 days
Proportion of patients achieving ≥30% reduction in pain intensity7 days
Proportion of patients achieving ≥50% reduction in pain intensity7 days
Follow-up time point with greatest reduction in pain intensity7 days
Proportion of patients by severity of lumbar muscle spasm assessed by Investigator's Global Subjective Assessment7 days
Oswestry Disability Questionnaire7 days
Roland-Morris Disability Questionnaire7 days

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