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

NCT06863662 | Completed Phase 3 DMC

• 1 other identifier: SIL-30951-III-23(1)
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute Low-back Pain; Back pain with muscle spams; Etoricoxib; Tizanidine

Outcome Measures

Primary Outcomes (2)

• Comparison of the percentage change in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 of follow-up relative to baseline, within each treatment group.

  The Visual Analog Scale (VAS) for pain is a straight line anchored by two descriptors: one end indicating no pain and the other representing the worst pain imaginable. The investigator will administer the VAS at each study visit to assess pain intensity. At the end of the clinical trial, the percentage change in pain scores from baseline will be calculated and compared between treatment groups.

  7 days

• Number of participants reporting treatment-related adverse events, as documented in the patient diary.

  To describe the frequency, intensity, and causality of adverse events reported during the clinical trial, stratified by treatment group. Adverse events will be recorded by patients in their diary logs. Each event will be monitored and followed up at the discretion of the investigator.

  7 days

Secondary Outcomes (7)

• Analyze the percentage change in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7, compared to baseline, within and between each treatment group.

  7 days

• Compare the proportion of patients in each treatment group who achieve a ≥30% reduction in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 relative to baseline.

  7 days

• Compare the proportion of patients in each treatment group who achieve a ≥50% reduction in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 relative to baseline.

  7 days

• Determine the follow-up time point at which each treatment group demonstrates the greatest reduction in pain intensity, as measured by the Visual Analog Scale (VAS).

  7 days

• Compare the proportion of patients in each treatment group according to the severity of lumbar muscle spasm, as assessed by the Investigator's Global Subjective Assessment.

  7 days

Other Outcomes (3)

• Report the percentage of therapeutic adherence on Day 7 of the intervention, in each treatment group.

  7 days

• Report the number of patients in each treatment group who require the use of rescue medication during the clinical trial.

  7 days

• Report the number of patients who experience therapeutic failure during the study, stratified by treatment group.

  7 days

Study Arms (2)

Etoricoxib+Tizanidine

EXPERIMENTAL

Administered orally, 1 sachet a day for 7 days.

Drug: Etoricoxib + Tizanidine fixed dose

Etoricoxib

ACTIVE COMPARATOR

Administered orally, 1 sachet a day for 7 days.

Drug: Etoricoxib fixed dose

Interventions

Etoricoxib + Tizanidine fixed dose DRUG

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

Also known as: Etori + Tiza

Etoricoxib+Tizanidine

Etoricoxib fixed dose DRUG

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

Also known as: Etori

Etoricoxib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate in the study and provide written informed consent.
• Diagnosis of acute low back pain, either as a first-time episode or following a previous episode within the past 6 months, with a duration not exceeding 6 weeks.
• Pain associated with lumbar muscle spasm, assessed through physical examination (muscle hypertonia and/or reflex scoliosis) and clinical history.
• Patient reports moderate to severe pain intensity (VAS ≥ 40 mm).
• Patients with a Neuropathic Pain Questionnaire (DN4) score \< 4.
• For women of childbearing age who are sexually active, the use of an acceptable contraceptive method (barrier and/or hormonal) as determined by the investigator.
• At the discretion of the Principal Investigator (PI) or treating physician, the patient is eligible for treatment with the investigational product and may benefit from it.

You may not qualify if:

• Patients with a history of hypersensitivity to any components of the investigational product (Etoricoxib/Tizanidine) or their derivatives (as reported in the medical history and clinical interview).
• Patients participating in another clinical trial involving an investigational treatment or who have participated in one within the past 2 weeks before the study begins.
• Patients whose participation in the study may be influenced (e.g., employment relationship with the research center or sponsor, vulnerable populations, etc.).
• Patients for whom the investigational drug is contraindicated for medical reasons.
• Positive pregnancy test, pregnant women, breastfeeding women, or those planning a pregnancy during the study period.
• Significant history of gastrointestinal disorders (e.g., active gastric ulcer, Crohn's disease, ulcerative colitis, etc.).
• Prior treatment with opioids and/or NSAIDs, including COX-2 inhibitors, as reported in the medical history within 48 hours before study enrollment.
• Patients with a history of congestive heart failure: NYHA class II-IV.
• Concomitant use of potent CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, etc.).
• History of alcohol or drug abuse within the past year.
• Patients with a history of established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease (including patients who have recently undergone coronary revascularization procedures or angioplasty).
• Patients with a history of seizure disorders, status epilepticus, or grand mal seizures.
• History of liver disease classified as Child-Pugh A, B, or C, as reported in the medical history or clinical interview.
• History of acute or severe renal failure (glomerular filtration rate \<30 ml/min/1.73 m²), as reported in the medical history or clinical interview.
• Patients with a history of chronic musculoskeletal pain (e.g., fibromyalgia, Paget's disease, cancer-induced metastatic bone pain).

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, Mexico City, 11000, Mexico

Location

Related Publications (7)

• Baumgartner PC, Haynes RB, Hersberger KE, Arnet I. A Systematic Review of Medication Adherence Thresholds Dependent of Clinical Outcomes. Front Pharmacol. 2018 Nov 20;9:1290. doi: 10.3389/fphar.2018.01290. eCollection 2018.

  PMID: 30524276 BACKGROUND

• Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

  PMID: 16079372 BACKGROUND

• Kovacs FM, Llobera J, Gil Del Real MT, Abraira V, Gestoso M, Fernandez C, Primaria Group KA. Validation of the spanish version of the Roland-Morris questionnaire. Spine (Phila Pa 1976). 2002 Mar 1;27(5):538-42. doi: 10.1097/00007632-200203010-00016.

  PMID: 11880841 BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

• Perez C, Galvez R, Huelbes S, Insausti J, Bouhassira D, Diaz S, Rejas J. Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component. Health Qual Life Outcomes. 2007 Dec 4;5:66. doi: 10.1186/1477-7525-5-66.

  PMID: 18053212 BACKGROUND

• van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM; Cochrane Back Review Group. Muscle relaxants for nonspecific low back pain: a systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1978-92. doi: 10.1097/01.BRS.0000090503.38830.AD.

  PMID: 12973146 BACKGROUND

• Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.

  PMID: 15370723 BACKGROUND

MeSH Terms

Conditions

Spasm; Back Pain

Interventions

Etoricoxib; tizanidine

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lilia E Acevedo-Rojas, MD

  Oaxaca Site Management Organization, S.C.

  PRINCIPAL INVESTIGATOR

• Mauricio Flores-Araujo, MD

  Mérida/ Investigación Clínica

  PRINCIPAL INVESTIGATOR

• Salvador Perez-Jaime, MD

  Centro de Investigación Médica Aguascalientes (CIMA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: September 18, 2024
• Primary Completion: September 26, 2025
• Study Completion: December 1, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)