Clinical trial NCT06516094: Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low-back Pain
Keywords: Low-back pain
Chronic pain
Vitamin B
Pregabalin
Celecoxib
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 B versus Celecoxib + Vitamin B, versus Pregabalin + Vitamin B in the treatment of chronic low back pain.

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the percentage change of Celecoxib / Pregabalin / Vitamin B Combination versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B in the management of chronic low back pain through the visual analog pain scale (VAS).
timeFrame: 3 months
measure: Number of participants with treatment-related adverse events through the patient's diary record.
timeFrame: 3 months
Secondary outcomes:
measure: To describe the sociodemographic characteristics of the patients included in the study by treatment group
timeFrame: 3 months
measure: Assess the proportion of patients who reported >30% improvement in pain intensity measured through VAS at 12 weeks per treatment group
timeFrame: 3 months
measure: Assess the proportion of patients who reported >50% improvement in pain intensity measured through VAS at 12 weeks per treatment group
timeFrame: 3 months
measure: Assess at what time of follow-up the greatest reduction in pain intensity was achieved, measured through VAS, per treatment group.
timeFrame: 3 months
measure: Assess and compare the degree of physical disability due to low back pain, measured through the Oswestry disability questionnaire at 4 and 12 weeks per treatment group.
timeFrame: 3 months
measure: Assess and compare the degree of disability to perform daily activities due to low back pain, reported through Roland-Morris questionnaire at 4 and 12 weeks per group treatment
timeFrame: 3 months
measure: Assess and compare health status through the 5-level, 5-dimensions EuroQol questionnaire (EQ-5D-5L) at 12 weeks from baseline in each group of treatment
timeFrame: 3 months
measure: Report the number of patients that required dose escalation
timeFrame: 3 months
measure: Report the number of patients who require the use of rescue medication during the clinical trial by treatment group.
timeFrame: 3 months
measure: Report the number of patients who presented therapeutic failure during the study among the treatment groups
timeFrame: 3 months
measure: To report the percentage of therapeutic adherence at 12 weeks of intervention by group of treatment.
timeFrame: 3 months
measure: Blood concentration of BUN of the patients included in the study by treatment group
timeFrame: 3 months
measure: Blood concentration of glucose of the patients included in the study by treatment group
timeFrame: 3 months
measure: Blood concentration of urea of the patients included in the study by treatment group
timeFrame: 3 months
measure: Blood concentration of creatinin of the patients included in the study by treatment group
timeFrame: 3 months
measure: Blood concentration of Alkaline Phosphatase of the patients included in the study by treatment group
timeFrame: 3 months
measure: Blood concentration of total bilirrubin of the patients included in the study by treatment group
timeFrame: 3 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Clínica de Ozonoterapia RGH, A.C.
name: Juan L Torres-Méndez
role: PRINCIPAL_INVESTIGATOR
affiliation: CICMEX
name: Raul Coca-Nuñez
role: PRINCIPAL_INVESTIGATOR
affiliation: Imacen S.A. de C.V.
name: Adelfia Urenda-Quezada
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicios Avanzados de Investigación Medica Mediadvance S.C.
name: Ma. Dolores Alonso-Martinez
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Institute, S.C.
name: Ramon F Villalobos-Bojorquez
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultorio Médico "Dr. Rodrigo Suárez Otero"
name: Rodrigo Suárez-Otero
role: PRINCIPAL_INVESTIGATOR
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