Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction

Last updated: February 6, 2025
Sponsor: Apsen Farmaceutica S.A.
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

APSCTC

Toragesic®

Tramal®

Clinical Study ID

NCT04647435
APS001/2020
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Males and Females aged 18 to 40 years;

  • Ability to confirm voluntary participation and agree to all trial purposes bysigning and dating the informed consent forms;

  • Participants who require extraction of impacted mandibular third molar.

Exclusion

Main Exclusion Criteria:

  • Known hypersensitivity to the formula components used during the clinical trial;

  • Previous history of alcohol or drugs abuse diagnosed by DSM-V;

  • Previous history of renal failure from moderate to severe;

  • Women who are pregnant, lactating, or positive for β - hCG urine test.

Study Design

Total Participants: 396
Treatment Group(s): 3
Primary Treatment: APSCTC
Phase: 3
Study Start date:
May 13, 2023
Estimated Completion Date:
October 04, 2024

Connect with a study center

  • Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

    Valinhos, São Paulo
    Brazil

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.