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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2020-03-27

Brief Summary

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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.

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Detailed Description

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* 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

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Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EMS association

The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.

Group Type EXPERIMENTAL

ketoprofen and cyclobenzaprine association

Intervention Type DRUG

The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.

Miosan®

The patient will take 2 tablets (cyclobenzaprine isolated), oral, per day, each 12h.

Group Type ACTIVE_COMPARATOR

Cyclobenzaprine

Intervention Type DRUG

The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.

Interventions

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ketoprofen and cyclobenzaprine association

The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.

Intervention Type DRUG

Cyclobenzaprine

The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.

Intervention Type DRUG

Other Intervention Names

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EMS association Miosan®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No