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Completed

NCT Number: NCT02862977

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Associação dos funcionários públicos do estado do RGS, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketoprofen and cyclobenzaprine association with caffeine

Drug

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

Other names: EMS association

Cyclobenzaprine with caffeine

Drug

The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h

Other names: Miosan Caf®

Primary outcomes

  1. 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 outcomes

  1. Safety will be evaluated by the adverse events occurrences

    Time frame: Maximal experiment duration: 9 days

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2016
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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