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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04647435

Acronym

CARLOTA

Enrollment

396

Registered

2020-12-01

Start date

2023-05-13

Completion date

2024-10-04

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postsurgical Pain, Third Molar Extraction

Brief summary

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

Interventions

DRUGAPSCTC

APSCTC + Toragesic® placebo + Tramal® placebo

DRUGToragesic®

APSCTC placebo + Toragesic® + Tramal® placebo

DRUGTramal®

APSCTC placebo + Toragesic® placebo + Tramal®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Adverse events incidence and classification	During treatment

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026