Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain
CompletedPhase 3NCT06516094
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 B versus Celecoxib + Vitamin B, versus Pregabalin + Vitamin B in the treatment of chronic low back pain.
Study details
- Official title
- Efficacy and Safety Study of Celecoxib / Pregabalin / Vitamin B Fixed Dose Combination Versus Celecoxib + Vitamin B Versus Pregabalin + Vitamin B in the Management of Chronic Low Back Pain Mixed Component
- Conditions
- Interventions
- Drug: Celecoxib+Pregabalin+Vitamin B fixed dose
- Drug: Celecoxib + Vitamin B fixed dose
- Drug: Pregabalin + Vitamin B fixed dose
- Sponsor
- Laboratorios Silanes S.A. de C.V.
- Start date
- 2024-04-11
- Primary completion
- 2025-01-01
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Mexico
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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 …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06516094