Status:
COMPLETED
Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Chronic 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 security of the drug combination of Celecoxib / Pregabalin / Vitamin...
Detailed Description
Researchers will compare the fixed-dose combination of Celecoxib/Pregabalin/Vitamin B versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B for chronic low back pain. The adverse events related t...
Eligibility Criteria
Inclusion
- Agree to participate in the study and give written informed consent
- Subjects must have chronic low back pain with a high probability of a significant neuropathic component during 4 years or less (but not less than 3 months)
- Patients with chronic low back pain reported as moderate to severe intensity (EVA ≥ 40 mm)
- Patients with Neuropathic Pain Questionnaire (DN4) result ≥ 4
- 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 whose 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
- 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.)
- Current treatment with opioids and/or NSAIDs including COX-2 inhibitors (except celecoxib), reported in clinical history in the last 24 hours to the signing of the informed consent
- Patients who are receiving monoamineoxidase inhibitors (MAOIs) or who have received them in the course of the 2 weeks prior to signing the informed consent
- 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
- History of major trauma to the lower back in the past 14 days
- Low back pain due to a visceral disorder (e.g., dysmenorrhea, history of endometriosis)
- Patients with a history of orthopedic surgery of the lumbar region secondary to chronic low back pain
- 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 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2025
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06516094
Start Date
April 11 2024
End Date
January 7 2025
Last Update
April 4 2025
Active Locations (1)
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1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000