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

Sponsor

EMS (Industry)

Overall Status

Completed

CT.gov ID

NCT02862977

Collaborator

(none)

414

Enrollment

Locations

Arms

25.3

Actual Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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 plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Pain	Drug: ketoprofen and cyclobenzaprine association with caffeine Drug: Cyclobenzaprine with caffeine	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

414 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 10, 2017

Actual Primary Completion Date :

Jun 5, 2019

Actual Study Completion Date :

Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Miosan Caf®

Arm

Intervention/Treatment

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 Names:

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 Names:

Miosan Caf®

Outcome Measures

Primary Outcome Measures

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

Safety will be evaluated by the adverse events occurrences [Maximal experiment duration: 9 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Associação dos funcionários públicos do estado do RGS	Porto Alegre	RS	Brazil
2	Centro de Medicina Reprodutiva Dr Carlos Isaia Filho	Porto Alegre	RS	Brazil
3	CECIP JAU - Centro De Estudos Clinicos do Interior Paulista	Jau	SP	Brazil
4	AFIP -Associação Fundo de Incentivo a Pesquisa	São Paulo	SP	Brazil
5	Allegisa	Campinas	São Paulo	Brazil	13.084-791
6	Marcio Antonio Pereira Clinica de Endocrinologia	São José dos Campos	São Paulo	Brazil