Efficacy and Safety of Dexketoprofen/Vitamin B Vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II

NCT05001555 | Completed Phase 3

• 1 other identifier: SIL-30242-III-20 (1)
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Low Back Pain

Outcome Measures

Primary Outcomes (5)

• Changes in pain intensity

  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.

  Baseline, 3, 5 and 7 days

• Change in the degree of disability

  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.

  Baseline, 3, 5 and 7 days

• Proportion of subjects requiring rescue medication

  Compare the proportion of subjects requiring rescue medication during the study between treatment groups.

  7 days

• Adverse events frequency

  Compare the proportion of subjects that presented an adverse event between treatment groups.

  7 days

• Adverse events intensity

  Compare the intensity of adverse events presented during the study, between treatment groups.

  7 days

Study Arms (2)

Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin)

EXPERIMENTAL

Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin), 1 capsule, orally, every 8 hours, for 7 days.

Drug: Dexketoprofen/Vitamin B

Group B: Dexketoprofen

ACTIVE COMPARATOR

Group B: Dexketoprofen, 1 tablet, orally, every 8 hours, for 7 days.

Drug: Dexketoprofen

Interventions

Dexketoprofen/Vitamin B DRUG

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.

Also known as: D/VitB

Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin)

Dexketoprofen DRUG

1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.

Also known as: D

Group B: Dexketoprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Mexico City, Mexico City, 11000, Mexico

Location

Related Publications (13)

• 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.

  PMID: 7604354 BACKGROUND

• 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.

  PMID: 15170609 BACKGROUND

• 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.

  PMID: 11148643 BACKGROUND

• 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.

  PMID: 29023870 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.

  PMID: 22135737 BACKGROUND

• 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.

  PMID: 12516888 BACKGROUND

• 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.

  PMID: 20037567 BACKGROUND

• 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.

  PMID: 2138683 BACKGROUND

• 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.

  PMID: 14699896 BACKGROUND

• 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.

  PMID: 19731994 BACKGROUND

• 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.

  PMID: 11247324 BACKGROUND

• 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.

  PMID: 28540716 BACKGROUND

• 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.

  PMID: 38842764 DERIVED

MeSH Terms

Interventions

dexketoprofen trometamol; Folic Acid; Fumigant 93

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pamela Delgado García, M.D

  IMACEN 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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 12, 2021
• Study Start: November 23, 2021
• Primary Completion: April 24, 2023
• Study Completion: April 25, 2023
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)