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

Last updated: February 23, 2021
Sponsor: EMS
Overall Status: Completed

Phase

3

Condition

Chronic Pain

Muscle Pain

Acute Pain

Treatment

N/A

Clinical Study ID

NCT03025113
EMS0116
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients with any clinically significant disease that in the investigator is opinioncan´t participate in the study;
  • Patients with any laboratory finding or image finding that in the investigator isopinion 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 orgastritis;
  • Renal or hepatic impairment.

Study Design

Total Participants: 416
Study Start date:
March 08, 2018
Estimated Completion Date:
March 27, 2020

Study 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

Connect with a study center

  • Allegisa

    Campinas, São Paulo 13.084-791
    Brazil

    Site Not Available

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