Clinical trial NCT06517823: Efficacy and Safety of Etoricoxib/Cyanocobalamin Versus Etoricoxib for Acute Low Back Pain
Official title: Efficacy and Safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in the Treatment of Patients with Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Low-back Pain
Keywords: Acute Low -back Pain
Acute pain
Etoricoxib
Cyanocobalamin
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: Researchers will compare the fixed-dose combination of Etoricoxib/Cyanocobalamin versus Etoricoxib in acute low back pain by comparing the proportion of patients that reported an improvement in pain during the 7 days of follow up. The adverse events related to the interventions will be registered during follow up.

Participants will:

* Be randomized into one of the 2 intervention groups (A or B)
* Visit the clinic in 3 occasions (day 0, day 3 of follow up and day 7 of follow up)
* In case needed the patient could take 50 mg of tramadol, as a rescue medication, previous authorization of de principal investigator

Eligibility criteria: Inclusion Criteria:

* Agree to participate in the study and give written informed consent
* Patient with pain reported as moderate to severe intensity with ≥ 40 mm on the Visual Analog Scale (VAS).
* At least 4 points on the "Douleur Neuropathique-4 items" (DN-4) scale.
* Diagnosis of acute low back pain as a first-time episode or a previous episode 6 months before the enrollment day and lasting no more than 6 weeks.
* Women of childbearing potential under a medically acceptable method of contraception

Exclusion Criteria:

* Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
* Patients in whom the participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
* At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures
* History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the efficacy and safety of the investigational product
* Patients in whom the study drug is contraindicated for medical reasons
* Patients with allergy or hypersensitivity to the active substance of the study drugs, related products or excipients (Etoricoxib of Cyanocobalamin)
* Pregnant women, women breastfeeding or planning a pregnancy during the conducting the study
* Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.)
* Active opioid and/or NSAID treatment including COX-2 inhibitors, reported in the medical record within the last 72 hours of study entry.
* Patients with a history of congestive heart failure: NYHA II-IV.
* Concomitant use of strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, etc.).
* Patients with a history of alcohol or drug abuse in the last year
* Patients with a history of ischemic heart disease, peripheral artery disease, and/or cerebral vascular disease (including patients who have recently undergone coronary revascularization or angioplasty)
* Patients with a history of seizures, epileptic status and/or grand mal seizures
* History of chronic liver failure Child-Pugh A, B, and/or C
* History of acute renal failure (glomerular filtration rate \<30 ml/min/1.72 m2)
* Patient with a history of chronic pain associated with fibromyalgia, Paget's disease or bone pain induced by metastatic cancer
* Low back pain due to a history of major trauma in the past 12 months (e.g., vertebral fracture, post-traumatic spondylolisthesis) or due to a visceral disorder (e.g., dysmenorrhea, history of endometriosis).
* Patients with symptoms suggestive of COVID-19 infection (fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19

Primary outcomes:
measure: 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
timeFrame: 7 dyas
measure: Number of participants with treatment-related adverse events through the patient's diary record.
timeFrame: 7 dyas
Secondary outcomes:
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: Report the number of patients who present therapeutic failure during the study among the treatment groups
timeFrame: 7 days
Other outcomes:
measure: To report the percentage of therapeutic adherence at day 7 of the intervention in each treatment group.
timeFrame: 7 days
measure: Report the number of patients who require the use of rescue medication during the clinical trial in each treatment group
timeFrame: 7 days
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Centro de Atención e Investigación Clínica S.C.
name: Ricardo Choza-Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicios Avanzados de Investigación Médica Mediadvance S.C.
name: Adelfia Urenda-Quezada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Institute S.C.
name: Isabel E Rucker Joerg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
name: Jesus H Mendoza-Ramírez, MD
role: PRINCIPAL_INVESTIGATOR
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