Trial · NCT06863662
Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm
NCT06863662, Phase 3, Completed, Laboratorios Silanes S.A. de C.V.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm. Trials, record NCT06863662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06863662
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm
- NCT number
- NCT06863662
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 136 participants, actual
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Conditions
- Acute Low-back Pain, Muscle Spasm; Back Pain
- Interventions
- Etoricoxib + Tizanidine fixed dose, Etoricoxib fixed dose
- First posted
- 2025-03-07
- Last updated
- 2026-01-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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. |
| Primary | Number of participants reporting treatment-related adverse events, as documented in the patient diary. | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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. | 7 days | 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. |
| Secondary | 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. | 7 days | 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. |
| Other | Report the percentage of therapeutic adherence on Day 7 of the intervention, in each treatment group. | 7 days | Therapeutic adherence will be defined by the principal investigator. Adherence will be considered adequate when the patient has taken ≥80% of the prescribed doses by the time of the corresponding evaluation. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06863662
GET https://conductscience.org/api/trials/v1/NCT06863662/registered