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

Primary Purpose

Acute Pain

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TIRADENTES ASSOCIATION
DIPYRONE
TRAMADOL
TIRADENTES ASSOCIATION PLACEBO
DIPYRONE PLACEBO
TRAMADOL PLACEBO
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Acute Pain

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    TIRADENTES

    DIPYRONE

    TRAMADOL

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Incidence and severity of adverse events recorded during the study.

    Full Information

    First Posted
    October 13, 2020
    Last Updated
    September 5, 2023
    Sponsor
    EMS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04593329
    Brief Title
    Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Strategy review
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain
    Keywords
    Acute Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TIRADENTES
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    DIPYRONE
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    TRAMADOL
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    TIRADENTES ASSOCIATION
    Intervention Description
    Tiradentes association tablet
    Intervention Type
    Drug
    Intervention Name(s)
    DIPYRONE
    Intervention Description
    Dipyrone 500 mg
    Intervention Type
    Drug
    Intervention Name(s)
    TRAMADOL
    Intervention Description
    Tramadol 50 mg
    Intervention Type
    Other
    Intervention Name(s)
    TIRADENTES ASSOCIATION PLACEBO
    Intervention Description
    Tiradentes association placebo tablet
    Intervention Type
    Other
    Intervention Name(s)
    DIPYRONE PLACEBO
    Intervention Description
    Dipyrone placebo tablet
    Intervention Type
    Other
    Intervention Name(s)
    TRAMADOL PLACEBO
    Intervention Description
    Tramadol placebo capsule
    Primary Outcome Measure Information:
    Title
    Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6)
    Description
    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.
    Time Frame
    0-6 hours
    Secondary Outcome Measure Information:
    Title
    Incidence and severity of adverse events recorded during the study.
    Time Frame
    26 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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

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