Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain

Study Overview
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Brief Summary
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Phase IIIb, longitudinal, multicenter, randomized, open-label clinical trial to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain.

Detailed Description
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Patients with back pain from the level of the lowest rib to the gluteal crease, with or without radiation to the legs, as a first-time episode or after another at least 6 months before and lasting no more than 6 weeks, that in the opinion of the doctor requires treatment with the combination of an anti-inflammatory and an analgesic. Study to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with the fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain. Evaluate and compare the average change in pain reported through the VAS at 3, 5 and 7 days with respect to its baseline measurement by treatment group. An exploratory analysis of the data will be carried out to identify aberrant, outliers, or missing values. To present the numerical variables, the measures of central tendency and dispersion appropriate to the distribution of the data will be used and the categorical variables will be expressed as frequency and percentage.

Official Title
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Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain.

Conditions
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Acute Low Back Pain

Intervention / Treatment
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* Drug: Etoricoxib 90 mg / Tramadol 50 mg
* Drug: Acetaminophen 325 mg / Tramadol 37.5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any sex. That the subject agree to participate in the study and give informed consent in writing. Age> 18 years and ≤ 60 years of age at the beginning of the study. Diagnosis of acute low back pain as a first-time episode or after another episode, maximum 6 months before and lasting no more than 6 weeks. Patient with low back pain reported as moderate to severe intensity (VAS> 4 cm). Women of childbearing age who have an acceptable contraceptive method (eg barrier, oral hormonal, injectable, subdermal). Exclusion Criteria: Patients in whom the study drug is contraindicated for medical reasons. Patients with an allergy or hypersensitivity to the active principle, study drugs, related products or excipients. Positive pregnancy test, women who are pregnant, breastfeeding or planning a pregnancy while conducting the study. A significant history of gastrointestinal disorders (for example: Gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.). Previous treatment with opioids and / or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) reported in the medical history in the last 72 hours at study entry. Patients with a history of alcohol or drug abuse in the last year according to DSM-V (Diagnostic and Statistical Manual of Mental Disorders). Patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have received them within the past 2 weeks. Patients with a history of established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty). Patients with status epileptic seizure disorders and grand mal seizures. Patients with a history of severe acute or chronic liver failure. Patients with a history of moderate to severe renal failure. Patient with a history of chronic pain (eg, fibromyalgia, Paget's disease, bone pain induced by metastatic cancer). Low back pain due to major trauma (eg vertebral fracture, post-traumatic spondylolisthesis), or due to a visceral disorder (eg dysmenorrhea, endometriosis). At medical criteria, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: intestinal obstruction, paralytic ileus, end-stage cancer, kidney, heart, respiratory or liver failure or mental illness or with surgical procedures or scheduled hospitals. History / presence of any disease or condition that, in the Investigator's opinion, could pose a risk to the patient or confuse the efficacy and safety of the study results. ----Patients with symptoms suggesting an active COVID-19 infection (i.e., fever, cough, dyspnea) and / or contact in the past 14 days with a suspected or positive COVID-19 patient. Oncological patients (except basal cell skin cancer) or with serious diseases that, in the opinion of the investigator, have a serious prognosis or a life expectancy of less than 1 year, as well as mental illnesses. The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks. Patients whose participation in the study may be influenced (employment relationship with the research center or sponsor, inmates, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Etoricoxib/Tramadol<br>Administered orally, one packet of etoricoxib / tramadol granules diluted in 100 ml of water, every 24 hours for 7 days. | Drug: Etoricoxib 90 mg / Tramadol 50 mg<br>* One packet diluted in 100 ml of water, every 24 hours of 90 mg/50 mg.<br>* Other names: E/T;|
| Active Comparator: Group B: Acetaminophen / Tramadol<br>Administered orally, one tablet, every 8 hours, for 7 days. | Drug: Acetaminophen 325 mg / Tramadol 37.5 mg<br>* One tablet, every 8 hours of 325 mg/ 37.5 m<br>* Other names: A/T;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change in reported pain | Compare the average change in pain reported through the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment | Baseline, 3, 5 and 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a 30% reduction in pain intensity | Describe the proportion of patients who reported a 30% reduction in pain intensity measure by the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment. | Baseline and 7 days. | 
| Degree of disability due to low back pain | Evaluate the degree of disability due to low back pain measured through the Oswestry disability scale per treatment group. It measures the limitations in daily activities in the presence of pain in the lumbar region, consists of 10 questions with 6 possible answers considering the intensity of the pain, basic activities of daily life such as: personal care, sexual activity, sleep, travel and social life. | Baseline and 7 days. | 
| Degree of inability to perform daily activities | Assess the degree of inability to perform daily activities through the Roland-Morris scale per group. It´s a self-applied scale where the extreme values range between 0 (absence of disability) and 24 (maximum disability) and is categorized according to the relevance of the score obtained where the optimal threshold of variation is 3 and 4 points. | Baseline and 7 days. | 
| Adverse events | Compare the frequency of adverse events presented during the study between the treatment groups. | 7 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back pain, Etoricoxib, Tramadol, Fixed dose