Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain
NCT Number: NCT06516094
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Low-back Pain
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.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-11
Completion Date: 2025-02-11
Locations: Laboratorio Silanes, S.A. de C.V., Mexico City, 11000, Mexico

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.

Primary Outcome Measures: 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)., The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the change porcentage will be measured and compared between treatment groups., 3 months|Number of participants with treatment-related adverse events through the patient's diary record., To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher., 3 months
Secondary Outcome Measures: To describe the sociodemographic characteristics of the patients included in the study by treatment group, A general description of sex, age, race, weight, height and BMI.

* Body weight: should be obtained on a scale, with the patient without shoes, in a standing position it would be recorded in kilograms.
* Height: must be obtained with a stadimeter, with the patient without shoes, in a standing position, the record will be in meters Height will be measured only at visit 0, and will be taken as a reference for measurement of BMI.
* BMI: calculated with the formula: Weight/height2 and will be recorded in kg/m2.

Weight and height will be combined to report BMI in kg/m\^2, 3 months|Assess the proportion of patients who reported >30% improvement in pain intensity measured through VAS at 12 weeks per treatment group, The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the proportion of patiens with an improvement of pain \>30% will be reported and compared between treatment groups., 3 months|Assess the proportion of patients who reported >50% improvement in pain intensity measured through VAS at 12 weeks per treatment group, The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the proportion of patiens with an improvement of pain \>50% will be reported and compared between treatment groups., 3 months|Assess at what time of follow-up the greatest reduction in pain intensity was achieved, measured through VAS, per treatment group., The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess time of greatest reduction in pain intensity., 3 months|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., The Oswestry questionnaire has been designed to give us information as to how the back pain has affected the ability to manage everyday life of patients, it classifies QOL as: no disability, mild disability, moderate disability, severe disability and completely disabled. The disability degree would be compared., 3 months|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, The Roland-Morris questionnaire has been designed to assess the activities of daily living functional mobility pain. A maximum score of 24 indicates the greatest degree of disability from pain. The disability degree would be compared., 3 months|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, The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS)The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'., 3 months|Report the number of patients that required dose escalation, Dose escalation criteria:

1. Increase in VAS values compared to the previous visit.
2. Use of rescue medication at least in three consecutive occasions.
3. Percentage of adherence to treatment ≥ 80% The researcher will assess the need for dose escalation or not in each visit., 3 months|Report the number of patients who require the use of rescue medication during the clinical trial by treatment group., The rescue medication will be tramadol 50 mg:

- The patient that considers the need for rescue medication must call the doctor, who will be in charge of applying the VAS scale by telephone. If the doctor considers it necessary, the taking of the rescue medication will be indicated., 3 months|Report the number of patients who presented therapeutic failure during the study among the treatment groups, Therapeutic failure will be defined by the principal researcher previous medical consult, the following criteria must be present:

* Increase in the parameters of the VAS scale at 12 weeks from baseline
* ≥80% to adherence to treatment
* The consumption of at least 2 doses of the designated group treatment
* The need of use of the rescue medication during 24 consecutive hours
* The absence of comorbidities that could increase the pain (knew traumatism during the clinical trial), 3 months|To report the percentage of therapeutic adherence at 12 weeks of intervention by group of treatment., Therapeutic adherence will be defined by the principal researcher. Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation., 3 months|Blood concentration of BUN of the patients included in the study by treatment group, A blood sample will be taken in each visit reporting BUN parameters. Comparisons of serum levels between groups will be made., 3 months|Blood concentration of glucose of the patients included in the study by treatment group, A blood sample will be taken in each visit reporting glucose parameters. Comparisons of serum levels between groups will be made., 3 months|Blood concentration of urea of the patients included in the study by treatment group, A blood sample will be taken in each visit reporting urea parameters. Comparisons of serum levels between groups will be made., 3 months|Blood concentration of creatinin of the patients included in the study by treatment group, A blood sample will be taken in each visit reporting creatinin parameters. Comparisons of serum levels between groups will be made., 3 months|Blood concentration of Alkaline Phosphatase of the patients included in the study by treatment group, A blood sample will be taken in each visit reporting Alkaline Phosphatase parameters. Comparisons of serum levels between groups will be made., 3 months|Blood concentration of total bilirrubin of the patients included in the study by treatment group, A blood sample will be taken in each visit reporting total bilirrubin parameters. Comparisons of serum levels between groups will be made., 3 months