- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593329
Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain
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
Study Overview
Status
Conditions
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TIRADENTES
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. |
Tiradentes association tablet
Dipyrone placebo tablet
Tramadol placebo capsule
|
Active Comparator: DIPYRONE
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. |
Tramadol placebo capsule
Dipyrone 500 mg
Tiradentes association placebo tablet
|
Active Comparator: TRAMADOL
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. |
Dipyrone placebo tablet
Tiradentes association placebo tablet
Tramadol 50 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0-6 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and severity of adverse events recorded during the study.
Time Frame: 26 days
|
26 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Acute Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Tramadol
- Dipyrone
Other Study ID Numbers
- EMS1519 - TIRADENTES 500/50
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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