Pain, ChronicPhase 2CANADÁNCT05125978

Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain

A Phase 2 study testing Canadá, Dipyrone and Tramadol hydrochloride in people with Pain, Chronic, run by EMS.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of Canadá association in the treatment of chronic pain Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Pain, Chronic
What is being tested?: Canadá, Dipyrone and Tramadol hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Sep 2026to Jul 2028
Phase: Phase 2
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;
Chronic pain during at least 3 months.

Who cannot join

Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;
History of alcohol abuse or illicit drug use;
Participation in a clinical trial in the year prior to this study;
Pregnancy or risk of pregnacy and lactating participants;
Known hypersensitivity to any of the formula compounds.

About this study

Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain

The purpose of this study is to evaluate the efficacy and safety of Canadá association in the treatment of chronic pain

Conditions: Pain, Chronic
Being tested: Canadá, Canadá placebo, Dipyrone, Dipyrone placebo, Tramadol hydrochloride
Keywords: Analgesia, Pain Management
Medical subject headings: Chronic Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CanadáDrug
Canadá association 1 tablet twice a day
Canadá placeboOther
Placebo of Canadá association 1 tablet twice a day
DipyroneDrug
Dipyrone 1 tablet twice a day
Dipyrone placeboOther
Placebo of dipyrone 1 tablet twice a day
Tramadol hydrochlorideDrug
Tramadol 1 coated tablet twice a day
Tramadol hydrochloride placeboOther
Placebo of tramadol 1 coated tablet twice a day

Study groups in NCT05125978
Study group	Role	What they receive
Canadá association	Experimental	The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet Canadá, oral; 1 placebo tablet of tramadol, oral; 1 placebo tablet of dipyrone, oral. Receives: Drug: Canadá; Other: Dipyrone placebo; Other: Tramadol hydrochloride placebo
Tramadol	Active comparator	The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet tramadol, oral; 1 placebo tablet of Canadá, oral; 1 placebo tablet of dipyrone, oral. Receives: Other: Canadá placebo; Other: Dipyrone placebo; Drug: Tramadol hydrochloride
Dipyrone	Active comparator	The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet dipyrone, oral; 1 placebo tablet of tramadol, oral; 1 placebo tablet of Canadá, oral. Receives: Other: Canadá placebo; Drug: Dipyrone; Other: Tramadol hydrochloride placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in pain intensity assessed by the VAS scale
Change from baseline in the pain intensity escores assessed in medical visits.
Measured: 12 weeks

Secondary outcomes (1)

Adverse events
Incidence and severity of adverse events recorded during the study
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Jul 2028

First posted18 Nov 2021
Study startSep 2026 (estimated)
Primary completionJul 2028 (estimated)
Study completionJul 2028 (estimated)

Why it stopped: Strategy review

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, ChronicStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05125978
Sponsor's protocol ID: EMS1120 - CANADÁ
Acronym: CANADÁ
Status last verified: Sep 2023
First submitted: 8 Nov 2021
Last updated: 8 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pain, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain
ClinicalTrials.gov ID: NCT05125978
Acronym / sponsor ID: CANADÁ / EMS1120 - CANADÁ
Conditions: Pain, Chronic
Keywords: Analgesia, Pain Management
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Strategy review
Enrolment: 0 participants (actual)
Lead sponsor: EMSIndustry (pharma, biotech, devices)
Study start: Sep 2026 (estimated)
Primary completion: Jul 2028 (estimated)
Study completion: Jul 2028 (estimated)
First posted: 18 Nov 2021 (actual)
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 efficacy and safety of Canadá association in the treatment of chronic pain

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Canadá association	Experimental	Drug: Canadá, Other: Dipyrone placebo, Other: Tramadol hydrochloride placeboThe study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet Canadá, oral; 1 placebo tablet of tramadol, oral; 1 placebo tablet of dipyrone, oral.
Tramadol	Active comparator	Other: Canadá placebo, Other: Dipyrone placebo, Drug: Tramadol hydrochlorideThe study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet tramadol, oral; 1 placebo tablet of Canadá, oral; 1 placebo tablet of dipyrone, oral.
Dipyrone	Active comparator	Other: Canadá placebo, Drug: Dipyrone, Other: Tramadol hydrochloride placeboThe study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet dipyrone, oral; 1 placebo tablet of tramadol, oral; 1 placebo tablet of Canadá, oral.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;
Chronic pain during at least 3 months.

Key exclusion criteria (5 listed)

Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;
History of alcohol abuse or illicit drug use;
Participation in a clinical trial in the year prior to this study;
Pregnancy or risk of pregnacy and lactating participants;
Known hypersensitivity to any of the formula compounds.

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
CanadáCanadá association 1 tablet twice a day	Drug	Canadá association
Canadá placeboPlacebo of Canadá association 1 tablet twice a day	Other	Dipyrone, Tramadol
DipyroneDipyrone 1 tablet twice a day	Drug	Dipyrone
Dipyrone placeboPlacebo of dipyrone 1 tablet twice a day	Other	Canadá association, Tramadol
Tramadol hydrochlorideTramadol 1 coated tablet twice a day	Drug	Tramadol
Tramadol hydrochloride placeboPlacebo of tramadol 1 coated tablet twice a day	Other	Canadá association, Dipyrone

Primary outcome

Difference in pain intensity assessed by the VAS scale
Time frame: 12 weeks
Change from baseline in the pain intensity escores assessed in medical visits.

1 secondary outcome

Adverse events
Time frame: 16 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.

Related trials for Pain, Chronic

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
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RecruitingObservational study
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Canadá, Dipyrone and Tramadol hydrochloride in people with Pain, Chronic, run by EMS.

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 5 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: withdrawn, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Difference in pain intensity assessed by the VAS scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05125978.

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 8 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.