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

November 23, 2023 updated by: Laboratorios Silanes S.A. de C.V.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Laboratorio Silanes, S.A. de C.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3, 5 and 7 days
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.
Baseline, 3, 5 and 7 days
Proportion of subjects requiring rescue medication
Time Frame: 7 days
Compare the proportion of subjects requiring rescue medication during the study between treatment groups.
7 days
Adverse events frequency
Time Frame: 7 days
Compare the proportion of subjects that presented an adverse event between treatment groups.
7 days
Adverse events intensity
Time Frame: 7 days
Compare the intensity of adverse events presented during the study, between treatment groups.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • 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: Pamela Delgado García, M.D, IMACEN S.A. de C.V.,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2021

Primary Completion (Actual)

April 24, 2023

Study Completion (Actual)

April 25, 2023

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30242-III-20 (1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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