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.

APS001/2020

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

2023-05-13

2024-09-01

2024-11-01

Recruiting

Early phase I

396

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 396, 'type': 'ESTIMATED'}}

2023-07-17