New combo pill aims to ease back pain and muscle spasms faster
NCT ID NCT06863662
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a fixed-dose combination of two drugs (etoricoxib and tizanidine) works better than etoricoxib alone for people with acute low back pain and muscle spasms. 136 adults with moderate to severe pain took part. The goal was to see if the combo reduces pain more effectively and safely over one week.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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136 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, 11000, Mexico
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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