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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib+Pregabalin+Vitamin B(thiamine mononitrate/pyridoxone hydrochloride/cyanocobalamin)+Placebo | Experimental | Administered orally, 1 tablet + 1 capsule a day, for 3 months. |
|
| Celecoxib + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin) | Active Comparator | Administered orally, 1 capsule + 1 tablet a day, for 3 months |
|
| Pregabalin + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin) | Active Comparator | Administered orally, 1 capsule + 1 tablet a day, for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
Weight and height will be combined to report BMI in kg/m^2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan L Torres-Méndez | ClÃnica 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Silanes, S.A. de C.V. | Mexico City | 11000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22135737 | Background | 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. | |
| 22299823 |
| Label | URL |
|---|---|
| Low back pain | View source |
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|
| Celecoxib + Vitamin B fixed dose | Drug | One capsule of 200 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day |
|
|
| Pregabalin + Vitamin B fixed dose | Drug | One capsule of 150 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day |
|
|
| 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:
| 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:
| 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 |
| 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. |
| 28860855 | Result | 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. |
| 22231424 | 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. |
| 27209166 | 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. |
| 21083513 | 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. |
| 34115979 | 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. |
| 30288088 | 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. |
| 27713336 | 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. |
| 29126136 | 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. |
| 22336956 | 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. |
| Non-steroidal anti-inflammatory drugs: an overview | View source |
| Nonsteroidal anti-inflammatory drugs in chronic pain: implications of new data for clinical practice | View source |
| National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 2662, Celecoxib | View source |
| National Center for Biotechnology Information | View source |
| National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 1130, Thiamine | View source |
| National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 1054, Pyridoxine | View source |
| National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 5311498, Cyanocobalamin | View source |
| Sample Size Calculator | View source |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D005492 | Folic Acid |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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