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

Phase 3CompletedNCT04647435

Apsen Farmaceutica S.A.396 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

396

Conditions

Postsurgical Pain Third Molar Extraction

Interventions

APSCTCDRUG

APSCTC + Toragesic® placebo + Tramal® placebo

Toragesic®DRUG

APSCTC placebo + Toragesic® + Tramal® placebo

Tramal®DRUG

APSCTC placebo + Toragesic® placebo + Tramal®

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

Valinhos, São Paulo, Brazil

Outcomes

Primary Outcomes

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

Time frame: Change from Baseline to 6 hours

Secondary Outcomes

Adverse events incidence and classification

Time frame: During treatment

Data from ClinicalTrials.gov

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