CompletedNCT02862977Updated Apr 2, 2020

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

A Phase 3 interventional study of ketoprofen and cyclobenzaprine association with caffeine and Cyclobenzaprine with caffeine in Musculoskeletal Pain, sponsored by EMS. Completed at 6 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-02.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 414
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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

Conditions studied

Musculoskeletal Pain

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Musculoskeletal Pain 493

In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's enrollment of 414 is above the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 414 participants (actual)

Study arms

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
Active comparator
Miosan Caf®
The patient will take 2 tablets (combination of Cyclobenzaprine and caffeine), oral, per day, each 12h.
Drug: Cyclobenzaprine with caffeine

Interventions

Drugketoprofen and cyclobenzaprine association with caffeine
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h
Also known as: EMS association
DrugCyclobenzaprine with caffeine
The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h
Also known as: Miosan Caf®

What researchers measure

Primary outcomes

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

Safety will be evaluated by the adverse events occurrences
Time frame: Maximal experiment duration: 9 days

Study locations

6 sites

Associação dos funcionários públicos do estado do RGS
Porto Alegre, RS, Brazil
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
Porto Alegre, RS, Brazil
CECIP JAU - Centro De Estudos Clinicos do Interior Paulista
Jau, SP, Brazil
AFIP -Associação Fundo de Incentivo a Pesquisa
São Paulo, SP, Brazil
Allegisa
Campinas, São Paulo 13.084-791, Brazil
Marcio Antonio Pereira Clinica de Endocrinologia
São José dos Campos, São Paulo, Brazil

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02862977
Lead sponsor: EMS
Responsible party: Sponsor
First posted: Aug 11, 2016
Start date: Nov 10, 2017
Primary completion: Jun 5, 2019
Completion: Dec 20, 2019
Last update: Apr 2, 2020

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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