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Trial record 12 of 46 for:    CYCLOBENZAPRINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03025113
Recruitment Status : Not yet recruiting
First Posted : January 19, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
EMS

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
Musculoskeletal Pain Drug: ketoprofen and cyclobenzaprine association Drug: Cyclobenzaprine 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 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
Estimated Study Start Date : March 15, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Miosan®




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. [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Safety will be evaluated by the adverse events occurrences [ Time Frame: Maximal experiment duration: 9 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025113


Contacts
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Contact: Roberto B. Amazonas, MD +551938879851 pesquisa.clinica@ems.com.br

Sponsors and Collaborators
EMS

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT03025113     History of Changes
Other Study ID Numbers: EMS0116
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cyclobenzaprine
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketoprofen
Amitriptyline
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators