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

NCT04593329 | Withdrawn Phase 2 DMC

• 1 other identifier: EMS1519 - TIRADENTES 500/50
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  0-6 hours

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  26 days

Study Arms (3)

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.

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.

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.

Drug: TRAMADOL; Other: TIRADENTES ASSOCIATION PLACEBO; Other: DIPYRONE PLACEBO

Interventions

TIRADENTES ASSOCIATION DRUG

Tiradentes association tablet

TIRADENTES

DIPYRONE DRUG

Dipyrone 500 mg

DIPYRONE

TRAMADOL DRUG

Tramadol 50 mg

TRAMADOL

TIRADENTES ASSOCIATION PLACEBO OTHER

Tiradentes association placebo tablet

DIPYRONE; TRAMADOL

DIPYRONE PLACEBO OTHER

Dipyrone placebo tablet

TIRADENTES; TRAMADOL

TRAMADOL PLACEBO OTHER

Tramadol placebo capsule

DIPYRONE; TIRADENTES

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Dipyrone; Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: March 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09