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

Sponsor
EMS (Industry)
Overall Status
Completed
CT.gov ID
NCT03025113
Collaborator
(none)
416
1
2
24.6
16.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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

Study Design

Study Type:
Interventional
Actual Enrollment :
416 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
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
Actual Study Start Date :
Mar 8, 2018
Actual Primary Completion Date :
Nov 29, 2019
Actual Study Completion Date :
Mar 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: EMS association

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

Drug: ketoprofen and cyclobenzaprine association
The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
Other Names:
  • EMS association
  • Active Comparator: Miosan®

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

    Drug: Cyclobenzaprine
    The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.
    Other Names:
  • Miosan®
  • Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Safety will be evaluated by the adverse events occurrences [Maximal experiment duration: 9 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allegisa Campinas São Paulo Brazil 13.084-791

    Sponsors and Collaborators

    • EMS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EMS
    ClinicalTrials.gov Identifier:
    NCT03025113
    Other Study ID Numbers:
    • EMS0116
    First Posted:
    Jan 19, 2017
    Last Update Posted:
    Feb 24, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2021