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

Study Overview
=================
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.

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.

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.

Conditions
-----------------
Acute Low Back Pain

Intervention / Treatment
-----------------
* Drug: Dexketoprofen/Vitamin B
* Drug: Dexketoprofen


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin)<br>Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin), 1 capsule, orally, every 8 hours, for 7 days. | Drug: Dexketoprofen/Vitamin B<br>* 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.<br>* Other names: D/VitB;|
| Active Comparator: Group B: Dexketoprofen<br>Group B: Dexketoprofen, 1 tablet, orally, every 8 hours, for 7 days. | Drug: Dexketoprofen<br>* 1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.<br>* Other names: D;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |