NCT02862977

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (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 plus caffeine compared to one anti-inflammatory plus caffeine 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 with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults. * Adverse events evaluation

Conditions

• Musculoskeletal Pain

Interventions

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

Timeline

• Start date: 2017-11-10
• Primary completion: 2019-06-05
• Completion: 2019-12-20
• First posted: 2016-08-11
• Last updated: 2020-04-02

Locations

6 sites across 1 country: Brazil