NCT03025113

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Musculoskeletal Pain

Interventions

Type	Name	Description
DRUG	ketoprofen and cyclobenzaprine association	The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
DRUG	Cyclobenzaprine	The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.

Timeline

• Start date: 2018-03-08
• Primary completion: 2019-11-29
• Completion: 2020-03-27
• First posted: 2017-01-19
• Last updated: 2021-02-24

Locations

1 site across 1 country: Brazil