Musculoskeletal PainPhase 3NCT02862977
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment
A Phase 3 study testing ketoprofen and cyclobenzaprine association with caffeine and Cyclobenzaprine with caffeine in people with Musculoskeletal Pain, run by EMS at 6 sites in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- ketoprofen and cyclobenzaprine association with caffeine and Cyclobenzaprine with caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 6 sitesBrazil
- Study dates
- 10 Nov 2017to 20 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Allegisa
Campinas, São Paulo, 13.084-791
CECIP JAU - Centro De Estudos Clinicos do Interior Paulista
Jaú, São Paulo
Associação dos funcionários públicos do estado do RGS
Porto Alegre, Rio Grande do Sul
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
Porto Alegre, Rio Grande do Sul
Marcio Antonio Pereira Clinica de Endocrinologia
São José dos Campos, São Paulo
AFIP -Associação Fundo de Incentivo a Pesquisa
São Paulo, São Paulo
About this study
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
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
- Musculoskeletal Pain
- Being tested
- ketoprofen and cyclobenzaprine association with caffeine, Cyclobenzaprine with caffeine
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoprofen and cyclobenzaprine association with caffeineDrug
Also called EMS association
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h
Cyclobenzaprine with caffeineDrug
Also called Miosan Caf®
The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h
| Study group | Role | What they receive |
|---|---|---|
| EMS association | Experimental | The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h. Receives: 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. Receives: Drug: Cyclobenzaprine with caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.
Measured: 48 hours
Secondary outcomes (1)
Safety will be evaluated by the adverse events occurrences
Measured: Maximal experiment duration: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start10 Nov 2017
- Primary completion5 Jun 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862977
- Sponsor's protocol ID
- EMS1415
- Status last verified
- Mar 2020
- First submitted
- 8 Aug 2016
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02862977
- Acronym / sponsor ID
- EMS1415
- Conditions
- Musculoskeletal Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMS association | Experimental | Drug: ketoprofen and cyclobenzaprine association with caffeineThe patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h. |
| Miosan Caf® | Active comparator | Drug: Cyclobenzaprine with caffeineThe patient will take 2 tablets (combination of Cyclobenzaprine and caffeine), oral, per day, each 12h. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketoprofen and cyclobenzaprine association with caffeineAlso: EMS associationThe patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h | Drug | EMS association |
| Cyclobenzaprine with caffeineAlso: Miosan Caf®The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h | Drug | Miosan Caf® |
Primary outcome
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
1 secondary outcome
Safety will be evaluated by the adverse events occurrences
Time frame: Maximal experiment duration: 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ketoprofen and cyclobenzaprine association with caffeine and Cyclobenzaprine with caffeine in people with Musculoskeletal Pain, run by EMS at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.