Efficacy and Safety of Dexketoprofen/Vitamin B vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II (WHIPLASH)

• ClinicalTrials.gov Identifier: NCT05001555
• Recruitment Status: Recruiting
• First Posted: August 12, 2021
• Last Update Posted: November 30, 2021
• Sponsor: Laboratorios Silanes S.A. de C.V.
• Information provided by (Responsible Party): Laboratorios Silanes S.A. de C.V.

Study Description

Brief Summary:

Phase IIIb, multicenter, prospective, randomized, double-blind study to evaluate the fixed combination of Desketoprofen / Vitamin B in the management of acute pain in patients with cervical sprain grade I-II of the Quebec scale.

Condition or disease	Intervention/treatment	Phase
Acute Low Back Pain	Drug: Dexketoprofen/Vitamin B; Drug: Dexketoprofen	Phase 3

Detailed Description:

Study to evaluate the efficacy and safety of the Dexketoprofen / Vitamin B combination versus dexketoprofen for the management of acute pain secondary to post-traumatic cervical sprain grade I-II of the Quebec scale, evaluated by means of the Visual Analogue Scale (VAS). To compare the degree of disability due to neck pain measured through the Northwick Park Neck Pain Questionnaire in Spanish version on days 3, 5, and 7 compare to its baseline measurement between the treatment groups. Compare the proportion of subjects requiring rescue medication during the study between treatment groups. Describe the frequency and intensity of adverse events presented during the study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 174 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of the Combination Dexketoprofen / Vitamin B vs Dexketoprofen in the Treatment of Pain in Patients With Post-traumatic Cervical Sprain Grade I-II of the Quebec Scale.
• Actual Study Start Date: November 29, 2021
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: June 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.; Other Name: D/VitB
Active Comparator: Group B: Dexketoprofen; Group B: Dexketoprofen, 1 tablet, orally, every 8 hours, for 7 days.	Drug: Dexketoprofen; 1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.; Other Name: D

Outcome Measures

Primary Outcome Measures :

1. Changes in pain intensity [ Time Frame: Baseline, 3, 5 and 7 days ]
   Compare changes in pain intensity measured by the visual analog scale (VAS) between treatment groups. The VAS for pain is a straight line of 10 centimeters in which one end means no pain and the other end means the worst pain imaginable.
2. Change in the degree of disability [ Time Frame: Baseline, 3, 5 and 7 days ]
   Compare the degree of disability due to neck pain measured through the Northwick Park Neck Pain Questionnaire Spanish version between the treatment groups. It includes 9 questions or items (intensity of neck pain, and sleep, pins and needles in the arms at night, duration of symptoms, lifting weights, reading and watching TV, work, social activities and driving). Each of these questions has five possible answers with a score of 0 to 4, from less to greater intensity and severity respectively.
3. Proportion of subjects requiring rescue medication [ Time Frame: 7 days ]
   Compare the proportion of subjects requiring rescue medication during the study between treatment groups.
4. Adverse events frequency [ Time Frame: 7 days ]
   Compare the proportion of subjects that presented an adverse event between treatment groups.
5. Adverse events intensity [ Time Frame: 7 days ]
   Compare the intensity of adverse events presented during the study, between treatment groups.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Any sex.
• 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:

• Patient in whom the drug is contraindicated for medical reasons.
• 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.

Contacts and Locations

Contacts

Contact: Jorge A González, PhD; 5254883785 ext 3761; jogonzalez@silanes.com.mx

Contact: Yulia Romero-Antonio, B.S.; 5554883700 ext 3777; yromero@silanes.com.mx

Locations

Mexico

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

Mexico City, Mexico, 11000

Contact: Jorge A Gonzalez, PhD +5254883785 ext 3761 jogonzalez@silanes.com.mx

Contact: Yulia Romero-Antonio, B.S. 5554883700 ext 3777 yromero@silanes.com.mx

Principal Investigator: Miguel A Zurqui Ramírez, M.D.

Principal Investigator: Adelfia Urenda Quezada, M.D.

Principal Investigator: Ma. Dolores Alonso Martínez, M.D.

Principal Investigator: Juan B Alcocer Herrera, M.D.

Sponsors and Collaborators

Laboratorios Silanes S.A. de C.V.

Investigators

• Principal Investigator: Miguel A Zurqui Ramírez, M.D; Icaro Investigación en Medicina S.A. de C.V.
• Principal Investigator: Adelfia Urenda Quezada, M.D; Mediadvance Clinical S.A.P.I. de C.V.
• Principal Investigator: Ma. Dolores Alonso Martínez, M.D; CICMEX Centro de Investigación Clínica de México
• Principal Investigator: Juan B Alcocer Herrera, M.D; INBIOMEDyC Querétaro

More Information

Publications:

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. Review. Erratum in: Spine 1995 Nov 1;20(21):2372.

Rodriquez AA, Barr KP, Burns SP. Whiplash: pathophysiology, diagnosis, treatment, and prognosis. Muscle Nerve. 2004 Jun;29(6):768-81. Review.

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.

Bagán JV, López Arranz JS, Valencia E, Santamaría J, Eguidazu I, Horas M, Forns M, Zapata A, Artigas R, Mauleón 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-Hernández AF, Monroy-Maya R, Soto-Ríos M, Carrillo-Alarcón L, Reyes-García G, Fernández-Martínez 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. Review.

Levin OS, Moseĭkin 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. German.

Pérez-Flores E, Medina-Santillán R, Reyes-García G, Mateos-García E. Combination of diclofenac plus B vitamins in acute pain after tonsillectomy: a pilot study. Proc West Pharmacol Soc. 2003;46:88-90.

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.

González T, Balsa A, Sáinz de Murieta J, Zamorano E, González 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:CD007355. doi: 10.1002/14651858.CD007355.pub3. Review.

• Responsible Party: Laboratorios Silanes S.A. de C.V.
• ClinicalTrials.gov Identifier: NCT05001555
• Other Study ID Numbers: SIL-30242-III-20 (1)
• First Posted: August 12, 2021
• Last Update Posted: November 30, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Low Back Pain; Back Pain; Pain; Neurologic Manifestations; Dexketoprofen trometamol; Physiological Effects of Drugs; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antirheumatic Agents