Acute Low-back PainPhase 3NCT06863662
Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm
A Phase 3 study testing Etoricoxib + Tizanidine fixed dose and Etoricoxib fixed dose in people with Acute Low-back Pain and Muscle Spasm; Back Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Low-back Pain, Muscle Spasm; Back Pain
- What is being tested?
- Etoricoxib + Tizanidine fixed dose and Etoricoxib fixed dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteMexico
- Study dates
- 18 Sep 2024to 1 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the 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
- Being tested
- Etoricoxib + Tizanidine fixed dose, Etoricoxib fixed dose
- Keywords
- Acute Low-back Pain, Back pain with muscle spams, Etoricoxib, Tizanidine
- Medical subject headings
- Spasm, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoricoxib + Tizanidine fixed doseDrug
Also called Etori + Tiza
One sachet with 120 mg / 4 mg, dissolved in 100 mL of water
Etoricoxib fixed doseDrug
Also called Etori
One sachet with 120 mg, dissolved in 100 mL of water
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib+Tizanidine | Experimental | Administered orally, 1 sachet a day for 7 days. Receives: Drug: Etoricoxib + Tizanidine fixed dose |
| Etoricoxib | Active comparator | Administered orally, 1 sachet a day for 7 days. Receives: Drug: Etoricoxib fixed dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
The Visual Analog Scale (VAS) for pain is a straight line anchored by two descriptors: one end represents the absence of pain, and the other indicates 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 across treatment groups. Patients will attend in-person visits on Days 0, 3, and 7 of follow-up, and the investigator will conduct follow-up phone calls on Days 1 and 5.
Measured: 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.
The Visual Analog Scale (VAS) for pain is a unidimensional tool consisting of 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. The proportion of patients achieving a reduction in pain of more than 30% from baseline will be recorded and compared across treatment groups on Days 1, 3, 5, and 7.
Measured: 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.
The Visual Analog Scale (VAS) for pain is a straight line anchored by two descriptors: one end represents the absence of pain, and the other indicates the worst pain imaginable. The investigator will administer the VAS at each study visit to evaluate pain intensity. The proportion of patients achieving a pain reduction greater than 30% from baseline will be documented and compared across treatment groups on Days 1, 3, 5, and 7.
Measured: 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).
The Visual Analog Scale (VAS) for pain is a unidimensional measurement tool represented by 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 the patient's pain intensity.
Measured: 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.
The investigator will assess the severity of lumbar muscle spasm using a global subjective scale, which will also allow evaluation of the muscle's response to movement following administration of the study treatment.
Measured: 7 days
Assess and compare the degree of physical disability caused by acute low back pain, as measured by the Oswestry Disability Questionnaire, on Days 3 and 7 in each treatment group, relative to baseline.
The Oswestry Disability Questionnaire is designed to assess how back pain affects a patient's ability to perform daily activities. It categorizes quality of life into five levels: no disability, mild disability, moderate disability, severe disability, and complete disability. The degree of disability will be assessed and compared between treatment groups.
Measured: 7 days
Assess and compare the degree of disability in performing daily activities due to low back pain, as reported using the Roland-Morris Disability Questionnaire, on Days 3 and 7 in each treatment group, relative to baseline.
The Roland-Morris Disability Questionnaire is designed to assess functional mobility and limitations in daily activities due to low back pain. It consists of 24 items, with higher scores indicating a greater degree of disability. A maximum score of 24 reflects the most severe disability. The degree of disability will be assessed and compared between treatment groups.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start18 Sep 2024
- Primary completion26 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lilia E Acevedo-Rojas, MD, Principal investigator, Oaxaca Site Management Organization, S.C.Mauricio Flores-Araujo, MD, Principal investigator, Mérida/ Investigación ClínicaSalvador Perez-Jaime, MD, Principal investigator, Centro de Investigación Médica Aguascalientes (CIMA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863662
- Sponsor's protocol ID
- SIL-30951-III-23(1)
- Status last verified
- Jan 2026
- First submitted
- 3 Mar 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30524276Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372Kovacs 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.
PubMed 11880841Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420Perez 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.
PubMed 18053212van 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.
PubMed 12973146Pallay 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.
PubMed 15370723
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06863662
- Acronym / sponsor ID
- SIL-30951-III-23(1)
- Conditions
- Acute Low-back Pain, Muscle Spasm; Back Pain
- Keywords
- Acute Low-back Pain, Back pain with muscle spams, Etoricoxib, Tizanidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib+Tizanidine | Experimental | Drug: Etoricoxib + Tizanidine fixed doseAdministered orally, 1 sachet a day for 7 days. |
| Etoricoxib | Active comparator | Drug: Etoricoxib fixed doseAdministered orally, 1 sachet a day for 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoricoxib + Tizanidine fixed doseAlso: Etori + TizaOne sachet with 120 mg / 4 mg, dissolved in 100 mL of water | Drug | Etoricoxib+Tizanidine |
| Etoricoxib fixed doseAlso: EtoriOne sachet with 120 mg, dissolved in 100 mL of water | Drug | Etoricoxib |
Primary outcome
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.
Time frame: 7 days
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.
Number of participants reporting treatment-related adverse events, as documented in the patient diary.
Time frame: 7 days
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 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 7 days
Assess and compare the degree of physical disability caused by acute low back pain, as measured by the Oswestry Disability Questionnaire, on Days 3 and 7 in each treatment group, relative to baseline.
Time frame: 7 days
Assess and compare the degree of disability in performing daily activities due to low back pain, as reported using the Roland-Morris Disability Questionnaire, on Days 3 and 7 in each treatment group, relative to baseline.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 30524276Baumgartner 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.
- Background: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Background: PubMed 11880841Kovacs 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.
- Background: PubMed 4139420Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- Background: PubMed 18053212Perez 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.
- Background: PubMed 12973146van 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.
- Background: PubMed 15370723Pallay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilia E Acevedo-Rojas, MD principal investigator
Oaxaca Site Management Organization, S.C.
Mauricio Flores-Araujo, MD principal investigator
Mérida/ Investigación Clínica
Salvador Perez-Jaime, MD principal investigator
Centro de Investigación Médica Aguascalientes (CIMA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoricoxib + Tizanidine fixed dose and Etoricoxib fixed dose in people with Acute Low-back Pain and Muscle Spasm; Back Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06863662, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.