Efficacy and Safety of Dexketoprofen/Vitamin B Vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II
NCT ID: NCT05001555
Last Updated: 2024-11-13
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
174 participants
INTERVENTIONAL
2021-11-23
2023-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin)
Group A:
Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin), 1 capsule, orally, every 8 hours, for 7 days.
Dexketoprofen/Vitamin B
1 capsule containing 25 mg of dexketoprofen / vitamin B (thiamine mononitrate 100 mg, Pyridoxine hydrochloride 50 mg, Cyanocobalamin 0.50 mg), orally, every 8 hours, for 7 days.
Group B: Dexketoprofen
Group B: Dexketoprofen, 1 tablet, orally, every 8 hours, for 7 days.
Dexketoprofen
1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.
Interventions
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Dexketoprofen/Vitamin B
1 capsule containing 25 mg of dexketoprofen / vitamin B (thiamine mononitrate 100 mg, Pyridoxine hydrochloride 50 mg, Cyanocobalamin 0.50 mg), orally, every 8 hours, for 7 days.
Dexketoprofen
1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* That the subject agree to participate in the study and give your written informed consent.
* Age\> 18 years old at the beginning of the study.
* Diagnosis of a grade I or Grade II cervical sprain on the Quebec scale of no more than 3 days.
* Visual Analog Scale (VAS) ≥4 cm.
* Women of childbearing potential using a contraceptive method (barrier, oral hormonal, injectable, subdermal), menopausal or surgically sterile.
Exclusion Criteria
* History of allergic reaction to NSAIDs, thiamine, pyridoxine and cyanocobalamin or hypersensitivity to the components of the formula.
* A significant history of gastrointestinal disorders (for example: Gastric Ulcer, Crohn's Disease, Ulcerative Colitis, etc.)
* Previous treatment with opioids reported in the medical history.
* History of inflammatory arthritis (eg rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout).
* History of chronic pain (eg, fibromyalgia), metastasis, and Paget's disease.
* History of alcohol or drug abuse in the last year according to DSM-V.
* Clinical and radiological data of cervical sprain grade III or IV of the Quebec scale.
* History of illness or injury for more than 6 months in the neck or cervical spine
* Patient with symptoms of spinal cord injury (weakness, incoordination or paralysis in any part of the body, numbness, tingling or loss of sensation in the hands, fingers, feet or toes, etc.)
* History of severe acute or chronic liver failure.
* History of moderate to severe renal failure.
* A significant history of coagulation problems (Von Willembrand, hemophilia, vitamin K deficiency, etc.).
* At medical discretion, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver failure or 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 to the patient or confuse the efficacy and safety of the study results.
* Oncological patients (except basal cell skin cancer) or with serious diseases that, in the opinion of the investigator, have a serious prognosis or a life expectancy of less than 1 year, as well as mental illnesses.
* Patients with symptoms suggesting an active COVID-19 infection (ie, fever, cough, dyspnea) and / or contact in the past 14 days with a suspected or positive COVID-19 patient.
* Patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
* Patients whose participation in the study may be influenced (employment relationship with the research center or sponsor, inmates, etc.)
* Positive pregnancy test, women who are pregnant, breastfeeding or planning a pregnancy while conducting the study.
18 Years
ALL
Yes
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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Pamela Delgado García, M.D
Role: PRINCIPAL_INVESTIGATOR
IMACEN S.A. de C.V.,
Adelfia Urenda Quezada, M.D
Role: PRINCIPAL_INVESTIGATOR
Mediadvance Clinical S.A.P.I. de C.V.
Ma. Dolores Alonso Martínez, M.D
Role: PRINCIPAL_INVESTIGATOR
CICMEX Centro de Investigación Clínica de México
Juan B Alcocer Herrera, M.D
Role: PRINCIPAL_INVESTIGATOR
INBIOMEDyC Querétaro
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, Mexico
Countries
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References
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Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine (Phila Pa 1976). 1995 Apr 15;20(8 Suppl):1S-73S. No abstract available.
Rodriquez AA, Barr KP, Burns SP. Whiplash: pathophysiology, diagnosis, treatment, and prognosis. Muscle Nerve. 2004 Jun;29(6):768-81. doi: 10.1002/mus.20060.
Hartling L, Brison RJ, Ardern C, Pickett W. Prognostic value of the Quebec Classification of Whiplash-Associated Disorders. Spine (Phila Pa 1976). 2001 Jan 1;26(1):36-41. doi: 10.1097/00007632-200101010-00008.
Bagan JV, Lopez Arranz JS, Valencia E, Santamaria J, Eguidazu I, Horas M, Forns M, Zapata A, Artigas R, Mauleon D. Clinical Comparison of Dexketoprofen Trometamol and Dipyrone in Postoperative Dental Pain. J Clin Pharmacol. 1998 Dec;38(S1):55S-64S. doi: 10.1002/jcph.1998.38.s1.55.
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.
Curatolo M, Sveticic G. Drug combinations in pain treatment: a review of the published evidence and a method for finding the optimal combination. Best Pract Res Clin Anaesthesiol. 2002 Dec;16(4):507-19. doi: 10.1053/bean.2002.0254.
Levin OS, Moseikin IA. [Vitamin B complex (milgamma) in the treatment of vertebrogenic lumbosacral radiculopathy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(10):30-5. Russian.
Kuhlwein A, Meyer HJ, Koehler CO. [Reduced diclofenac administration by B vitamins: results of a randomized double-blind study with reduced daily doses of diclofenac (75 mg diclofenac versus 75 mg diclofenac plus B vitamins) in acute lumbar vertebral syndromes]. Klin Wochenschr. 1990 Jan 19;68(2):107-15. doi: 10.1007/BF01646857. German.
Perez-Flores E, Medina-Santillan R, Reyes-Garcia G, Mateos-Garcia E. Combination of diclofenac plus B vitamins in acute pain after tonsillectomy: a pilot study. Proc West Pharmacol Soc. 2003;46:88-90. No abstract available.
Mibielli MA, Geller M, Cohen JC, Goldberg SG, Cohen MT, Nunes CP, Oliveira LB, da Fonseca AS. Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study. Curr Med Res Opin. 2009 Nov;25(11):2589-99. doi: 10.3111/13696990903246911.
Gonzalez T, Balsa A, Sainz de Murieta J, Zamorano E, Gonzalez I, Martin-Mola E. Spanish version of the Northwick Park Neck Pain Questionnaire: reliability and validity. Clin Exp Rheumatol. 2001 Jan-Feb;19(1):41-6.
Gaskell H, Derry S, Wiffen PJ, Moore RA. Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults. Cochrane Database Syst Rev. 2017 May 25;5(5):CD007355. doi: 10.1002/14651858.CD007355.pub3.
Delgado-Garcia P, Alcocer-Herrera JB, Urenda-Quezada A, Alonso-Martinez MD, Bautista-Mendoza MA, Romero-Antonio Y, Mora-Villalobos JC, Sander-Padilla JG, Rios-Brito KF, Rodriguez-Vazquez IC, Gonzalez-Canudas J. A Randomized Control Trial of Dexketoprofen/Vitamin B (Thiamine, Pyridoxine and Cyanocobalamin) Fixed-Dose Combination in Post-Traumatic Grade I-II Cervical Sprains. Clin Drug Investig. 2024 Jun;44(6):413-424. doi: 10.1007/s40261-024-01370-2. Epub 2024 Jun 6.
Other Identifiers
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SIL-30242-III-20 (1)
Identifier Type: -
Identifier Source: org_study_id
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