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

NCT03025113 | Completed Phase 3 DMC

• 1 other identifier: EMS0116
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.

  48 hours

Secondary Outcomes (1)

• Safety will be evaluated by the adverse events occurrences

  Maximal experiment duration: 9 days

Study Arms (2)

EMS association

EXPERIMENTAL

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

Drug: ketoprofen and cyclobenzaprine association

Miosan®

ACTIVE COMPARATOR

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

Drug: Cyclobenzaprine

Interventions

ketoprofen and cyclobenzaprine association DRUG

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

Also known as: EMS association

EMS association

Cyclobenzaprine DRUG

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

Also known as: Miosan®

Miosan®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Ketoprofen; cyclobenzaprine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: March 8, 2018
• Primary Completion: November 29, 2019
• Study Completion: March 27, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

BR (1)