Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain

Laboratorios Silanes

Status and phase: Completed; Phase 3

Conditions: Chronic Low-back Pain

Treatments: Drug: Celecoxib+Pregabalin+Vitamin B fixed dose; Drug: Celecoxib + Vitamin B fixed dose; Drug: Pregabalin + Vitamin B fixed dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06516094

SIL-30222-III-22 (1)

Details and patient eligibility

About

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.

Full 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 to the interventions would be registered in each follow up visit.

Participants will:

• Be randomized into one of the 3 intervention groups (A,B,C) once a day for 12 weeks
• If needed the dose could be escaleted twice a day.
• Visit the clinic at weeks 2, 4, 8 and 12 for checkups and follow up

Enrollment: 192 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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192 participants in 3 patient groups

Celecoxib+Pregabalin+Vitamin B(thiamine mononitrate/pyridoxone hydrochloride/cyanocobalamin)+Placebo

Experimental group

Description:

Administered orally, 1 tablet + 1 capsule a day, for 3 months.

Treatment:

Drug: Celecoxib+Pregabalin+Vitamin B fixed dose

Celecoxib + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)

Active Comparator group

Description:

Administered orally, 1 capsule + 1 tablet a day, for 3 months

Treatment:

Drug: Celecoxib + Vitamin B fixed dose

Pregabalin + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)

Active Comparator group

Description:

Administered orally, 1 capsule + 1 tablet a day, for 3 months

Treatment:

Drug: Pregabalin + Vitamin B fixed dose