Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain
NCT ID: NCT06516094
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
192 participants
INTERVENTIONAL
2024-04-11
2025-01-07
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Celecoxib+Pregabalin+Vitamin B(thiamine mononitrate/pyridoxone hydrochloride/cyanocobalamin)+Placebo
Administered orally, 1 tablet + 1 capsule a day, for 3 months.
Celecoxib+Pregabalin+Vitamin B fixed dose
One tablet of 200 mg / 150 mg / 100 mg / 50 mg / 0.50 mg + 1 capsule of placebo once a day
Celecoxib + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)
Administered orally, 1 capsule + 1 tablet a day, for 3 months
Celecoxib + Vitamin B fixed dose
One capsule of 200 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day
Pregabalin + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)
Administered orally, 1 capsule + 1 tablet a day, for 3 months
Pregabalin + Vitamin B fixed dose
One capsule of 150 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day
Interventions
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Celecoxib+Pregabalin+Vitamin B fixed dose
One tablet of 200 mg / 150 mg / 100 mg / 50 mg / 0.50 mg + 1 capsule of placebo once a day
Celecoxib + Vitamin B fixed dose
One capsule of 200 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day
Pregabalin + Vitamin B fixed dose
One capsule of 150 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Juan L Torres-Méndez
Role: PRINCIPAL_INVESTIGATOR
Clínica de Ozonoterapia RGH, A.C.
Raul Coca-Nuñez
Role: PRINCIPAL_INVESTIGATOR
CICMEX
Adelfia Urenda-Quezada
Role: PRINCIPAL_INVESTIGATOR
Imacen S.A. de C.V.
Ma. Dolores Alonso-Martinez
Role: PRINCIPAL_INVESTIGATOR
Servicios Avanzados de Investigación Medica Mediadvance S.C.
Ramon F Villalobos-Bojorquez
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Institute, S.C.
Rodrigo Suárez-Otero
Role: PRINCIPAL_INVESTIGATOR
Consultorio Médico "Dr. Rodrigo Suárez Otero"
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, , Mexico
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
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SIL-30222-III-22 (1)
Identifier Type: -
Identifier Source: org_study_id
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