Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment

Phase III, National, Multicenter, Randomized, Double-blind, Double-masked, Compare the Efficacy of Ketoprofen, Cyclobenzaprine and Caffeine Association Versus Cyclobenzaprine and Caffeine (Miosan Caf®) in the Treatment of Osteomuscular Pain in Adults

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.

• 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

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.