Status:
COMPLETED
Efficacy and Safety of Etoricoxib/Cyanocobalamin Versus Etoricoxib for Acute Low Back Pain
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Acute Low-back Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 Ve...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2024
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06517823
Start Date
April 26 2024
End Date
October 11 2024
Last Update
November 27 2024
Active Locations (1)
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1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, Mexico, 11000