Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment
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|ClinicalTrials.gov Identifier: NCT02862977|
Recruitment Status : Unknown
Verified January 2017 by EMS.
Recruitment status was: Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : January 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Pain||Drug: ketoprofen and cyclobenzaprine association with caffeine Drug: Cyclobenzaprine with caffeine||Phase 3|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||414 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Estimated Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||March 30, 2018|
|Estimated Study Completion Date :||June 29, 2018|
Experimental: EMS association
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h.
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
Other Name: EMS association
Active Comparator: Miosan Caf®
The patient will take 2 tablets (combination of 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
Other Name: Miosan Caf®
- 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 ]
- Safety will be evaluated by the adverse events occurrences [ Time Frame: Maximal experiment duration: 9 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862977
|Contact: Roberto B. Amazonas, MDfirstname.lastname@example.org|