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

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Acetaminophen; Etoricoxib; Tramadol

Criteria

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.).