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OpenTrials
Completed

NCT Number: NCT04647435

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.

Completed

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Key information

Conditions

Postsurgical Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Third Molar Extraction

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

Valinhos, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APSCTC

Drug

APSCTC + Toragesic® placebo + Tramal® placebo

Toragesic®

Drug

APSCTC placebo + Toragesic® + Tramal® placebo

Tramal®

Drug

APSCTC placebo + Toragesic® placebo + Tramal®

Primary outcomes

  1. At least 50% of maximum pain relief score (TOTPARmax)

    Time frame: Change from Baseline to 6 hours

Secondary outcomes

  1. Adverse events incidence and classification

    Time frame: During treatment

Sponsors and collaborators

Lead sponsor

Apsen Farmaceutica S.A.

Industry

Registry information

Official study 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.

Acronym: CARLOTA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2020
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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