NCT02862977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

August 8, 2016

Last Update Submit

March 31, 2020

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

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

    48 hours

Secondary Outcomes (1)

  • Safety will be evaluated by the adverse events occurrences

    Maximal experiment duration: 9 days

Study Arms (2)

EMS association

EXPERIMENTAL

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

Miosan Caf®

ACTIVE COMPARATOR

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

Drug: Cyclobenzaprine with caffeine

Interventions

ketoprofen and cyclobenzaprine association with caffeineDRUG

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

Also known as: EMS association
EMS association
Cyclobenzaprine with caffeineDRUG

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

Also known as: Miosan Caf®
Miosan Caf®

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Associação dos funcionários públicos do estado do RGS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho

Porto Alegre, Rio Grande do Sul, Brazil

Location

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

Location

CECIP JAU - Centro De Estudos Clinicos do Interior Paulista

Jaú, São Paulo, Brazil

Location

Marcio Antonio Pereira Clinica de Endocrinologia

São José dos Campos, São Paulo, Brazil

Location

AFIP -Associação Fundo de Incentivo a Pesquisa

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

KetoprofenCaffeinecyclobenzaprine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 11, 2016

Study Start

November 10, 2017

Primary Completion

June 5, 2019

Study Completion

December 20, 2019

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations

BR(6)