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

Overview

The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.

Full Title of Study: “Phase III, National, Multicenter, Randomized, Double-blind, Double-masked, Compare the Efficacy of Ketoprofen, Cyclobenzaprine and Caffeine Association Versus Cyclobenzaprine and Caffeine (Miosan Caf®) in the Treatment of Osteomuscular Pain in Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 5, 2019

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 with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults. – Adverse events evaluation

Interventions

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

Arms, Groups and Cohorts

  • Experimental: EMS association
    • The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h.
  • Active Comparator: Miosan Caf®
    • The patient will take 2 tablets (combination of Cyclobenzaprine and caffeine), oral, per day, each 12h.

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.
    • Time Frame: 48 hours

Secondary Measures

  • Safety will be evaluated by the adverse events occurrences
    • Time Frame: Maximal experiment duration: 9 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMS
  • Provider of Information About this Clinical Study
    • Sponsor

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