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

EMS416 enrolled

Overview

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.

* 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

416

Conditions

Musculoskeletal Pain

Interventions

ketoprofen and cyclobenzaprine associationDRUG

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

CyclobenzaprineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Allegisa

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.

Time frame: 48 hours

Secondary Outcomes

Safety will be evaluated by the adverse events occurrences

Time frame: Maximal experiment duration: 9 days

Data from ClinicalTrials.gov

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