Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment
Primary Purpose
Musculoskeletal Pain
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
ketoprofen and cyclobenzaprine association
Cyclobenzaprine
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain
Eligibility Criteria
IInclusion 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.
Sites / Locations
- Allegisa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EMS association
Miosan®
Arm Description
The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
The patient will take 2 tablets (cyclobenzaprine isolated), oral, per day, each 12h.
Outcomes
Primary Outcome Measures
Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.
Secondary Outcome Measures
Safety will be evaluated by the adverse events occurrences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03025113
Brief Title
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
March 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
416 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMS association
Arm Type
Experimental
Arm Description
The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
Arm Title
Miosan®
Arm Type
Active Comparator
Arm Description
The patient will take 2 tablets (cyclobenzaprine isolated), oral, per day, each 12h.
Intervention Type
Drug
Intervention Name(s)
ketoprofen and cyclobenzaprine association
Other Intervention Name(s)
EMS association
Intervention Description
The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
Intervention Type
Drug
Intervention Name(s)
Cyclobenzaprine
Other Intervention Name(s)
Miosan®
Intervention Description
The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Time Frame
Maximal experiment duration: 9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
IInclusion 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.
Facility Information:
Facility Name
Allegisa
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13.084-791
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment
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