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

EMS

Status and phase

Completed

Phase 3

Conditions

Musculoskeletal Pain

Treatments

Drug: Cyclobenzaprine with caffeine

Drug: ketoprofen and cyclobenzaprine association with caffeine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02862977

EMS1415

Details and patient eligibility

About

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.

Full 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

Enrollment

414 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.