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

Musculoskeletal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025113
• Other study ID #: EMS0116
• Status: Completed
• Phase: Phase 3
• Start date: March 8, 2018
• Est. completion date: March 27, 2020

Study information

• Verified date: February 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: March 27, 2020
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Allegisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.		48 hours
Secondary	Safety will be evaluated by the adverse events occurrences		Maximal experiment duration: 9 days