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

Phase 3

Completed

• Conditions: Musculoskeletal Pain
• Interventions: Drug: ketoprofen and cyclobenzaprine association; Drug: Cyclobenzaprine

• Registration Number: NCT03025113
• Lead Sponsor: EMS

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 agent compared to the one muscle relaxant agent isolated 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 compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults.

* Adverse events evaluation

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-19
• Study Start: 2018-03-08
• Primary Completion: 2019-11-29
• Study Completion: 2020-03-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMS association	ketoprofen and cyclobenzaprine association	The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
Miosan®	Cyclobenzaprine	The patient will take 2 tablets (cyclobenzaprine isolated), oral, per day, each 12h.

Primary Outcome Measures

Name	Time	Method
Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.	48 hours

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences	Maximal experiment duration: 9 days

Trial Locations

Locations (1)

Allegisa; 🇧🇷 Campinas, São Paulo, Brazil