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

EMS

Status and phase: Completed; Phase 3

Conditions: Musculoskeletal Pain

Treatments: Drug: ketoprofen and cyclobenzaprine association; Drug: Cyclobenzaprine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03025113

EMS0116

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 agent compared to the one muscle relaxant agent isolated 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 compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults.
• Adverse events evaluation

Enrollment: 416 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

IInclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

416 participants in 2 patient groups

EMS association

Experimental group

Description:

The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.

Treatment:

Drug: ketoprofen and cyclobenzaprine association

Miosan®

Active Comparator group

Description:

The patient will take 2 tablets (cyclobenzaprine isolated), oral, per day, each 12h.

Treatment:

Drug: Cyclobenzaprine