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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Postsurgical Pain; Third Molar Extraction
• Intervention / Treatment: Drug: APSCTC; Drug: Toragesic®; Drug: Tramal®

• Study Type: Interventional
• Enrollment (Estimated): 396
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Fernanda Martinez, B.Sc.; Phone Number: 8404 +551156448200; Email: fernanda.martinez@apsen.com.br

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil
      • Recruiting
      • Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
      • Contact: Joyce Macedo da Silva, MD; Phone Number: +55 11 981794142; Email: joyce.macedo@azidusbrasil.com.br
      • Principal Investigator: Joyce Macedo da Silva, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 β - hCG urine test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APSCTC; Oral tablets every 6h for 3 days	Drug: APSCTC; APSCTC + Toragesic® placebo + Tramal® placebo
Active Comparator: Toragesic®; Oral tablets every 6h for 3 days	Drug: Toragesic®; APSCTC placebo + Toragesic® + Tramal® placebo
Active Comparator: Tramal®; Oral tablets every 6h for 3 days	Drug: Tramal®; APSCTC placebo + Toragesic® placebo + Tramal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
At least 50% of maximum pain relief score (TOTPARmax)	Change from Baseline to 6 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events incidence and classification	During treatment

Collaborators and Investigators

• Sponsor: Apsen Farmaceutica S.A.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: APS001/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No