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

Postsurgical Pain Clinical Trial

— CARLOTA  

Official title:

National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04647435
• Other study ID #: APS001/2020
• Status: Recruiting
• Phase: Phase 3
• Start date: May 13, 2023
• Est. completion date: November 2024

Study information

• Verified date: July 2023
• Source: Apsen Farmaceutica S.A.
• Contact: Fernanda Martinez, B.Sc.
• Phone: +551156448200
• Email: fernanda.martinez[@]apsen.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Main Inclusion Criteria:

• Males and Females aged 18 to 40 years;
• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Participants who require extraction of impacted mandibular third molar.

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 ß - hCG urine test.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain
• Third Molar Extraction

Intervention

Drug:
• APSCTC
APSCTC + Toragesic® placebo + Tramal® placebo
• Toragesic®
APSCTC placebo + Toragesic® + Tramal® placebo
• Tramal®
APSCTC placebo + Toragesic® placebo + Tramal®

Locations

Country	Name	City	State
Brazil	Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Apsen Farmaceutica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At least 50% of maximum pain relief score (TOTPARmax)		Change from Baseline to 6 hours
Secondary	Adverse events incidence and classification		During treatment