Efficacy and Safety of Etoricoxib/Cyanocobalamin Versus Etoricoxib for Acute Low Back Pain
NCT Number: NCT06517823
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Low-back Pain
Interventions: DRUG: Etoricoxib + Cyanocobalamin fixed dose|DRUG: Etoricoxib fixed dose
Sponsor: Laboratorios Silanes S.A. de C.V.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-22
Completion Date: 2025-01-22
Locations: Laboratorio Silanes, S.A. de C.V., Mexico City, 11000, Mexico

Summary:
Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in Patients With Acute Low Back Pain

Primary Outcome Measures: Comparison of the proportion of patients reporting pain improvement (reduction in pain intensity with a VAS ≤20 mm) at 1, 3, 5, and 7 days of follow-up, according to their baseline measurement in each treatment group, The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the change porcentage will be measured and compared between treatment groups.

The patient will visit the clinic at days 0,3 and 7. The researcher will call the patient for follow up at days 1 and 5., 7 dyas|Number of participants with treatment-related adverse events through the patient's diary record., To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher., 7 dyas
Secondary Outcome Measures: Analyze the average change in pain intensity according to VAS score at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement., The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the change porcentage will be measured and compared between treatment groups.

The patient will visit the clinic at days 0,3 and 7. The researcher will call the patient for follow up at days 1 and 5., 7 days|Analyze the percentage change in pain intensity based on VAS score at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement., % change= ((Final Measurement-Initial Measurement)/(Initial Measurement))\*100, 7 days|Comparison of the proportion of subjects with pain improvement (reduction in pain intensity) through VAS, ≥ 30% at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement., The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. The proportion of patiens with an improvement of pain \>30% will be reported and compared between treatment groups at days 1,3,5 and 7., 7 days|Comparison of the proportion of subjects with pain improvement (reduction in pain intensity) through VAS, ≥ 50% at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement., The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. The proportion of patiens with an improvement of pain \>30% will be reported and compared between treatment groups at days 1,3,5 and 7., 7 days|Assess and compare the degree of physical disability due to acute low back pain, measured through the Oswestry disability questionnaire at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement., The Oswestry questionnaire has been designed to give us information as to how the back pain has affected the ability to manage everyday life of patients, it classifies QOL as: no disability, mild disability, moderate disability, severe disability and completely disabled. The disability degree would be compared., 7 days|Assess and compare the degree of disability to perform daily activities due to low back pain, reported through Roland-Morris questionnaire at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement., The Roland-Morris questionnaire has been designed to assess the activities of daily living functional mobility pain. A maximum score of 24 indicates the greatest degree of disability from pain. The disability degree will be compared., 7 days|Assess changes in the score on the "Douleur Neuropathique-4 items" scale (DN-4) at days 3 and 7 in each treatment group and in comparison with the baseline measurement., The DN4 is a clinician-administered, neuropathic pain diagnostic questionnaire, consisting of ten items grouped in four sections. The first seven items are related to the quality of pain (burning, painful cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching). The other three items are related to neurological examination in the painful area (touch hypoesthesia, pinprick hypoesthesia, tactile allodynia)., 7 days|Report the number of patients who present therapeutic failure during the study among the treatment groups, Therapeutic failure will be defined by the principal researcher previous medical consult, the following criteria must be present:

- When there is a decrease \<10 mm or increase in VAS values compared to baseline and a ≥ 80% adherence to treatment, 7 days
Other Outcome Measures: To report the percentage of therapeutic adherence at day 7 of the intervention in each treatment group., Therapeutic adherence will be defined by the principal researcher. Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation., 7 days|Report the number of patients who require the use of rescue medication during the clinical trial in each treatment group, The rescue medication will be tramadol 50 mg:

- The patient that considers the need for rescue medication must call the doctor, who will be in charge of applying the VAS scale by telephone. If the doctor considers it necessary, the taking of the rescue medication will be indicated., 7 days