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

NCT06516094 | Completed Phase 3 DMC

• 1 other identifier: SIL-30222-III-22 (1)
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Low-back pain; Chronic pain; Vitamin B; Pregabalin; Celecoxib

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• To describe the sociodemographic characteristics of the patients included in the study by treatment group

  3 months

• Assess the proportion of patients who reported >30% improvement in pain intensity measured through VAS at 12 weeks per treatment group

  3 months

• Assess the proportion of patients who reported >50% improvement in pain intensity measured through VAS at 12 weeks per treatment group

  3 months

• Assess at what time of follow-up the greatest reduction in pain intensity was achieved, measured through VAS, per treatment group.

  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.

  3 months

Study Arms (3)

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

EXPERIMENTAL

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

Drug: Celecoxib+Pregabalin+Vitamin B fixed dose

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

ACTIVE COMPARATOR

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

Drug: Celecoxib + Vitamin B fixed dose

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

ACTIVE COMPARATOR

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

Drug: Pregabalin + Vitamin B fixed dose

Interventions

Celecoxib+Pregabalin+Vitamin B fixed dose DRUG

One tablet of 200 mg / 150 mg / 100 mg / 50 mg / 0.50 mg + 1 capsule of placebo once a day

Also known as: Cele+Pre+Vit B

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

Celecoxib + Vitamin B fixed dose DRUG

One capsule of 200 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day

Also known as: Cele+Vit B

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

Pregabalin + Vitamin B fixed dose DRUG

One capsule of 150 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day

Also known as: Pre+Vit B

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

Location

Related Publications (11)

• Ponce-Monter HA, Ortiz MI, Garza-Hernandez AF, Monroy-Maya R, Soto-Rios M, Carrillo-Alarcon L, Reyes-Garcia G, Fernandez-Martinez E. Effect of diclofenac with B vitamins on the treatment of acute pain originated by lower-limb fracture and surgery. Pain Res Treat. 2012;2012:104782. doi: 10.1155/2012/104782. Epub 2011 Oct 31.

  PMID: 22135737 BACKGROUND

• Antonucci R, Zaffanello M, Puxeddu E, Porcella A, Cuzzolin L, Pilloni MD, Fanos V. Use of non-steroidal anti-inflammatory drugs in pregnancy: impact on the fetus and newborn. Curr Drug Metab. 2012 May 1;13(4):474-90. doi: 10.2174/138920012800166607.

  PMID: 22299823 BACKGROUND

• Raffaeli W, Arnaudo E. Pain as a disease: an overview. J Pain Res. 2017 Aug 21;10:2003-2008. doi: 10.2147/JPR.S138864. eCollection 2017.

  PMID: 28860855 RESULT

• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

  PMID: 22231424 RESULT

• Kongsted A, Kent P, Axen I, Downie AS, Dunn KM. What have we learned from ten years of trajectory research in low back pain? BMC Musculoskelet Disord. 2016 May 21;17:220. doi: 10.1186/s12891-016-1071-2.

  PMID: 27209166 RESULT

• Morlion B. Pharmacotherapy of low back pain: targeting nociceptive and neuropathic pain components. Curr Med Res Opin. 2011 Jan;27(1):11-33. doi: 10.1185/03007995.2010.534446. Epub 2010 Nov 18.

  PMID: 21083513 RESULT

• Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8.

  PMID: 34115979 RESULT

• Ho KY, Gwee KA, Cheng YK, Yoon KH, Hee HT, Omar AR. Nonsteroidal anti-inflammatory drugs in chronic pain: implications of new data for clinical practice. J Pain Res. 2018 Sep 20;11:1937-1948. doi: 10.2147/JPR.S168188. eCollection 2018.

  PMID: 30288088 RESULT

• Ajmone-Cat MA, Bernardo A, Greco A, Minghetti L. Non-Steroidal Anti-Inflammatory Drugs and Brain Inflammation: Effects on Microglial Functions. Pharmaceuticals (Basel). 2010 Jun 14;3(6):1949-1965. doi: 10.3390/ph3061949.

  PMID: 27713336 RESULT

• Wishart DS, Feunang YD, Guo AC, Lo EJ, Marcu A, Grant JR, Sajed T, Johnson D, Li C, Sayeeda Z, Assempour N, Iynkkaran I, Liu Y, Maciejewski A, Gale N, Wilson A, Chin L, Cummings R, Le D, Pon A, Knox C, Wilson M. DrugBank 5.0: a major update to the DrugBank database for 2018. Nucleic Acids Res. 2018 Jan 4;46(D1):D1074-D1082. doi: 10.1093/nar/gkx1037.

  PMID: 29126136 RESULT

• Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available.

  PMID: 22336956 RESULT

Related Links

• Low back pain
• Non-steroidal anti-inflammatory drugs: an overview
• Nonsteroidal anti-inflammatory drugs in chronic pain: implications of new data for clinical practice
• National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 2662, Celecoxib
• National Center for Biotechnology Information
• National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 1130, Thiamine
• National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 1054, Pyridoxine
• National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 5311498, Cyanocobalamin
• Sample Size Calculator

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Celecoxib; Folic Acid; Pregabalin

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Juan L Torres-Méndez

  Clínica de Ozonoterapia RGH, A.C.

  PRINCIPAL INVESTIGATOR

• Raul Coca-Nuñez

  CICMEX

  PRINCIPAL INVESTIGATOR

• Adelfia Urenda-Quezada

  Imacen S.A. de C.V.

  PRINCIPAL INVESTIGATOR

• Ma. Dolores Alonso-Martinez

  Servicios Avanzados de Investigación Medica Mediadvance S.C.

  PRINCIPAL INVESTIGATOR

• Ramon F Villalobos-Bojorquez

  Clinical Research Institute, S.C.

  PRINCIPAL INVESTIGATOR

• Rodrigo Suárez-Otero

  Consultorio Médico "Dr. Rodrigo Suárez Otero"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 23, 2024
• Study Start: April 11, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 7, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)