Acute PainPhase 2NCT04593329

Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain

A Phase 2 study testing TIRADENTES ASSOCIATION, DIPYRONE and TRAMADOL in people with Acute Pain, 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Withdrawn

Withdrawn.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 Tiradentes association in adolescents and adults with acute pain. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Acute Pain
What is being tested?: TIRADENTES ASSOCIATION, DIPYRONE and TRAMADOL
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: Mar 2023to Dec 2023
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 informed consent forms;
Participants of both sexes, aged 15 years or more;
Participants who require extraction of impacted mandibular third molar;
Third molar with bone impactions observed in panoramic radiography, with classification of Winter (1926) mesioangular or vertical, and classification according to Pell \& Gregory (1933) class II position B or class III position A or B;
Participants with acute pain of moderate or severe intensity after completion of surgery.

Who cannot join

Known hypersensitivity to the formula components used during the clinical trial;
History of alcohol and/or substance abuse within 2 years;
Participants whose surgery for molar extraction lasted more than 50 minutes;
Participants with known gastroduodenal ulcers or diagnosis of persistent gastritis;
Participants who used sedatives or hypnotic agents before surgery;
Anesthesia technical failure or need for more than three anesthetic tubes;

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Participants with temporomandibular joint dysfunction or limited mouth opening;
Surgical accident that, in the investigator's opinion, may interfere with the procedures or evaluations of the trial;
Postoperative complications such as, but not restricted to: neuropraxia and paresthesia;
Participants who used any medication that acts on the pain mechanism in the 3 days prior to the start of the trial;
Participants under chronic opioid treatment.

About this study

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

The purpose of this study is to evaluate the efficacy and safety of Tiradentes association in adolescents and adults with acute pain.

Conditions: Acute Pain
Being tested: TIRADENTES ASSOCIATION, DIPYRONE, TRAMADOL, TIRADENTES ASSOCIATION PLACEBO, DIPYRONE PLACEBO
Keywords: Acute Pain
Medical subject headings: Acute Pain

What participants receive

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

TIRADENTES ASSOCIATIONDrug
Tiradentes association tablet
DIPYRONEDrug
Dipyrone 500 mg
TRAMADOLDrug
Tramadol 50 mg
TIRADENTES ASSOCIATION PLACEBOOther
Tiradentes association placebo tablet
DIPYRONE PLACEBOOther
Dipyrone placebo tablet
TRAMADOL PLACEBOOther
Tramadol placebo capsule

Study groups in NCT04593329
Study group	Role	What they receive
TIRADENTES	Experimental	The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 tablet Tiradentes association, oral; 1 capsule tramadol placebo, oral; 1 tablet dipyrone placebo, oral. Receives: Drug: TIRADENTES ASSOCIATION; Other: DIPYRONE PLACEBO; Other: TRAMADOL PLACEBO
DIPYRONE	Active comparator	The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 tablet dipyrone, oral; 1 tablet Tiradentes association placebo, oral; 1 capsule tramadol placebo, oral. Receives: Drug: DIPYRONE; Other: TIRADENTES ASSOCIATION PLACEBO; Other: TRAMADOL PLACEBO
TRAMADOL	Active comparator	The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 capsule tramadol, oral; 1 tablet dipyrone placebo, oral; 1 tablet Tiradentes association placebo, oral. Receives: Drug: TRAMADOL; Other: TIRADENTES ASSOCIATION PLACEBO; Other: DIPYRONE PLACEBO

What is being measured

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

Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6)
Sum of pain intensity differences after 6 hours (SPID0-6), calculated as the weighted sum of pain intensity scale over 6 hours after the dose. Scoring is derived from the 4-point scale, which 0= no pain, 1= mild pain, 2= moderate pain and 4= severe pain.
Measured: 0-6 hours

Secondary outcomes (1)

Incidence and severity of adverse events recorded during the study.
Measured: 26 days

Timeline

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

Mar 2023Dec 2023

First posted20 Oct 2020
Study startMar 2023 (estimated)
Primary completionAug 2023 (estimated)
Study completionDec 2023 (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 Acute 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04593329
Sponsor's protocol ID: EMS1519 - TIRADENTES 500/50
Status last verified: Sep 2023
First submitted: 13 Oct 2020
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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A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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All Acute Pain 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 Tiradentes Association in the Treatment of Acute Pain
ClinicalTrials.gov ID: NCT04593329
Acronym / sponsor ID: EMS1519 - TIRADENTES 500/50
Conditions: Acute Pain
Keywords: Acute Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Strategy review
Enrolment: 0 participants (actual)
Lead sponsor: EMSIndustry (pharma, biotech, devices)
Study start: Mar 2023 (estimated)
Primary completion: Aug 2023 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 20 Oct 2020 (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 Tiradentes association in adolescents and adults with acute pain.

Study design

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

Arm	Type	Receives
TIRADENTES	Experimental	Drug: TIRADENTES ASSOCIATION, Other: DIPYRONE PLACEBO, Other: TRAMADOL PLACEBOThe study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 tablet Tiradentes association, oral; 1 capsule tramadol placebo, oral; 1 tablet dipyrone placebo, oral.
DIPYRONE	Active comparator	Drug: DIPYRONE, Other: TIRADENTES ASSOCIATION PLACEBO, Other: TRAMADOL PLACEBOThe patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 tablet dipyrone, oral; 1 tablet Tiradentes association placebo, oral; 1 capsule tramadol placebo, oral.
TRAMADOL	Active comparator	Drug: TRAMADOL, Other: TIRADENTES ASSOCIATION PLACEBO, Other: DIPYRONE PLACEBOThe patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 capsule tramadol, oral; 1 tablet dipyrone placebo, oral; 1 tablet Tiradentes association placebo, oral.

Who may qualify

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

Key inclusion criteria (5 listed)

Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
Participants of both sexes, aged 15 years or more;
Participants who require extraction of impacted mandibular third molar;
Third molar with bone impactions observed in panoramic radiography, with classification of Winter (1926) mesioangular or vertical, and classification according to Pell \& Gregory (1933) class II position B or class III position A or B;
Participants with acute pain of moderate or severe intensity after completion of surgery.

Key exclusion criteria (11 listed)

Known hypersensitivity to the formula components used during the clinical trial;
History of alcohol and/or substance abuse within 2 years;
Participants whose surgery for molar extraction lasted more than 50 minutes;
Participants with known gastroduodenal ulcers or diagnosis of persistent gastritis;
Participants who used sedatives or hypnotic agents before surgery;

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
TIRADENTES ASSOCIATIONTiradentes association tablet	Drug	TIRADENTES
DIPYRONEDipyrone 500 mg	Drug	DIPYRONE
TRAMADOLTramadol 50 mg	Drug	TRAMADOL
TIRADENTES ASSOCIATION PLACEBOTiradentes association placebo tablet	Other	DIPYRONE, TRAMADOL
DIPYRONE PLACEBODipyrone placebo tablet	Other	TIRADENTES, TRAMADOL
TRAMADOL PLACEBOTramadol placebo capsule	Other	DIPYRONE, TIRADENTES

Primary outcome

Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6)
Time frame: 0-6 hours
Sum of pain intensity differences after 6 hours (SPID0-6), calculated as the weighted sum of pain intensity scale over 6 hours after the dose. Scoring is derived from the 4-point scale, which 0= no pain, 1= mild pain, 2= moderate pain and 4= severe pain.

1 secondary outcome

Incidence and severity of adverse events recorded during the study.
Time frame: 26 days

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 Acute Pain

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)

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 TIRADENTES ASSOCIATION, DIPYRONE and TRAMADOL in people with Acute Pain, 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 5 inclusion and 11 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?

Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6) (time frame: 0-6 hours). 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 NCT04593329.

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.