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 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
174
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.
1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, Mexico
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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Adverse events frequency
Compare the proportion of subjects that presented an adverse event between treatment groups.
Time frame: 7 days
Adverse events intensity
Compare the intensity of adverse events presented during the study, between treatment groups.
Time frame: 7 days
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