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Completed
NCT04647435
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
Conditions: Postsurgical Pain, Third Molar Extraction
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 396
Sponsor: Apsen Farmaceutica S.A.
Location: Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda. Valinhos São Paulo
Summary
The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.
Eligibility 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.
Source: ClinicalTrials.gov (NCT04647435). StuddyBuddy aggregates publicly available trial information.
