Phase III clinical trial, multicentre of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of ibuprofen gel in the treatment of acute pain.
This study is designed for the relief of acute musculoskeletal pain, characterized by pain in muscles, ligaments, tendons, and nerves. It is performed in participants of both sexes, over 18 years of age, who have pain of moderate intensity as a result of ankle sprains, upper limb contusions, thigh muscle strains, or torticollis. The rationale for studying the topical use of ibuprofen is the possibility of an alternative treatment for musculoskeletal pain, avoiding systemic adverse events caused by oral administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Ibuprofen gel 5% topically four times a day
Placebo gel topically four times a day
Superiority of ibuprofen gel over placebo in the treatment of acute musculoskeletal pain.
The primary endpoint of the study is the proportion of participants achieving at least 50% pain reduction on day 5 of treatment by assessing pain intensity using the Visual Analog Scale (VAS), compared to baseline VAS. (Scale = 0 to 10; 0 = mild pain and 10 = severe pain)
Time frame: 5 days of treatment
Pain relief with study medication on days 3, 5, and 7.
Pain relief by the adapted Pain Relief (PAR) Scale, with the 5 categories: 0 - no relief, 1- slight relief, 2 - moderate relief, 3 - considerable relief, and 4 - complete relief, on days 3, 5, and 7.
Time frame: 3, 5 and 7 days of treatment
Interference of pain on physical activity on days 3, 5 and 7
Pain interference with physical activity by 4-point scale: 0 - no interference with physical activity; 1 - no restriction of physical activity, although some pain on movement; 2 - some restriction of physical activity, but not enough to prevent normal activity; 3 - unable to perform normal activities and with substantial limiting effects, on days 3, 5, and 7.
Time frame: 3, 5 and 7 days of treatment
Time needed for pain improvement.
Time needed for pain improvement (reduction of at least 50% of pain on the VAS scale)
Time frame: Through study completion, an average of 7 days
Obtain the overall assessment of effectiveness, performed by the participant at the end of the treatment.
Overall assessment of treatment by participant using 5-point scale: bad, fair, good, very good, and excellent.
Time frame: Through study completion, an average of 7 days
Obtain the overall efficacy evaluation, performed by the investigator at the end of the treatment.
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Overall assessment of treatment by physician using 5-point scale: bad, fair, good, very good, and excellent.
Time frame: Through study completion, an average of 7 days
Number of participants using rescue medication.
Time frame: Through study completion, an average of 7 days
Time to use of rescue medication.
Time frame: Through study completion, an average of 7 days