Comparing Etoricoxib with and without Tizanidine for Acute Low Back Pain

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

This study is testing whether adding tizanidine to etoricoxib can help people with acute low back pain and muscle spasms feel better compared to taking etoricoxib alone.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Laboratorios Silanes S.A. de C.V. (industry)
• Locations: 1 site (Mexico City)
• Trial ID: NCT06863662 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of a fixed-dose combination of etoricoxib and tizanidine compared to etoricoxib alone in patients suffering from acute low back pain associated with muscle spasms. Participants will be randomized into two groups and will attend three in-person visits over a week, with follow-up phone calls to monitor their progress. The primary outcome will be the change in pain levels reported by patients, while adverse events will also be tracked throughout the study.

Who should consider this trial

Good fit: Ideal candidates are individuals experiencing moderate to severe acute low back pain with muscle spasms, either as a first-time episode or a recurrence within the last six months.

Not a fit: Patients with chronic back pain or those who have a history of hypersensitivity to the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from acute low back pain and muscle spasms.

How similar studies have performed: Previous studies have shown promising results with similar combinations of pain management medications, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Patients diagnosed with low back pain due to a history of major trauma within the past 12 months (e.g., vertebral fracture, post-traumatic spondylolisthesis), a visceral disorder (e.g., dysmenorrhea, history of endometriosis), or a neuropathic component.
* At the physician's discretion, any disease that affects prognosis and prevents outpatient management, which must be evaluated by the principal investigator to determine the subject's eligibility.
* History or presence of any disease or condition that, in the investigator's opinion, could pose a risk to the patient or confound the efficacy and safety assessment of the investigational product.
* Patients with symptoms suggesting an active COVID-19 infection (e.g., fever, cough, dyspnea) and/or contact with a suspected or confirmed COVID-19 case in the last 14 days.
* Oncology patients (except for basal cell skin cancer) or those with severe illnesses who, in the investigator's opinion, have a severe prognosis or a life expectancy of less than one year

Where this trial is running

Mexico City

• Laboratorio Silanes, S.A. de C.V. — Mexico City, Mexico (RECRUITING)

Study contacts

• Principal investigator: Lilia E Acevedo-Rojas, MD — Oaxaca Site Management Organization, S.C.
• Study coordinator: Jorge A Gonzalez, PhD

Conditions: Acute Low-back Pain, Muscle Spasm, Back Pain, Back pain with muscle spams, Etoricoxib, Tizanidine