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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Apsen Farmaceutica S.A.
• Treatments: Tramadol

Criteria

Main Inclusion Criteria:

• Males and Females aged 18 to 35 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.