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

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
ketoprofen and cyclobenzaprine association with caffeine
Cyclobenzaprine with caffeine
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Associação dos funcionários públicos do estado do RGS
  • Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
  • CECIP JAU - Centro De Estudos Clinicos do Interior Paulista
  • AFIP -Associação Fundo de Incentivo a Pesquisa
  • Allegisa
  • Marcio Antonio Pereira Clinica de Endocrinologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EMS association

Miosan Caf®

Arm Description

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

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

Outcomes

Primary Outcome Measures

Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.

Secondary Outcome Measures

Safety will be evaluated by the adverse events occurrences

Full Information

First Posted
August 8, 2016
Last Updated
March 31, 2020
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT02862977
Brief Title
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMS association
Arm Type
Experimental
Arm Description
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h.
Arm Title
Miosan Caf®
Arm Type
Active Comparator
Arm Description
The patient will take 2 tablets (combination of Cyclobenzaprine and caffeine), oral, per day, each 12h.
Intervention Type
Drug
Intervention Name(s)
ketoprofen and cyclobenzaprine association with caffeine
Other Intervention Name(s)
EMS association
Intervention Description
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h
Intervention Type
Drug
Intervention Name(s)
Cyclobenzaprine with caffeine
Other Intervention Name(s)
Miosan Caf®
Intervention Description
The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Time Frame
Maximal experiment duration: 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Associação dos funcionários públicos do estado do RGS
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
CECIP JAU - Centro De Estudos Clinicos do Interior Paulista
City
Jau
State/Province
SP
Country
Brazil
Facility Name
AFIP -Associação Fundo de Incentivo a Pesquisa
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Allegisa
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13.084-791
Country
Brazil
Facility Name
Marcio Antonio Pereira Clinica de Endocrinologia
City
São José dos Campos
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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