Musculoskeletal Pain
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.
Detailed description
* Double-blind,randomized, multicenter * Maximal experiment duration: 9 days * 02 or 03 visits and a phone contact * Evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults. * Adverse events evaluation
Interventions
DRUGketoprofen and cyclobenzaprine association with caffeine
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h
DRUGCyclobenzaprine with caffeine
The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Signed Consent of the patient; * Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS (visual analog scale) greater than 40 mm for a period of less than seven (7) days.
Exclusion criteria
* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study; * Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; * Patients with history of hypersensitivity to any of the formula compounds; * Participation in clinical trial in the year prior to this study; * Pregnancy or risk of pregnancy and lactating patients; * Patients who were in use of drugs that can interfere with evaluation; * History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis; * Renal or hepatic impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale. | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be evaluated by the adverse events occurrences | Maximal experiment duration: 9 days |
Countries
Brazil
Outcome results
None listed