Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 46 for:    CYCLOBENZAPRINE

Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02862977
Recruitment Status : Unknown
Verified January 2017 by EMS.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : January 23, 2017
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 plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.

Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Drug: ketoprofen and cyclobenzaprine association with caffeine Drug: Cyclobenzaprine with caffeine 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 with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults.
  • Adverse events evaluation

Layout table for study information
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 and Caffeine Association Versus Cyclobenzaprine and Caffeine (Miosan Caf®) in the Treatment of Osteomuscular Pain in Adults
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: EMS association
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h.
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
Other Name: EMS association

Active Comparator: Miosan Caf®
The patient will take 2 tablets (combination of 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
Other Name: Miosan Caf®




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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

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): NCT02862977


Contacts
Layout table for location contacts
Contact: Roberto B. Amazonas, MD +551938879851 pesquisa.clinica@ems.com.br

Sponsors and Collaborators
EMS

Layout table for additonal information
Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02862977     History of Changes
Other Study ID Numbers: EMS1415
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cyclobenzaprine
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketoprofen
Amitriptyline
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs