Efficacy and Safety of Dexketoprofen/Vitamin B Vs Dexketoprofen for Post-traumatic Cervical Sprai… (NCT05001555) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Dexketoprofen/Vitamin B Vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II
Mexico174 participantsStarted 2021-11-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, et…
What they're measuring
1
Changes in pain intensity
Timeframe: Baseline, 3, 5 and 7 days
2
Change in the degree of disability
Timeframe: Baseline, 3, 5 and 7 days
3
Proportion of subjects requiring rescue medication