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

Apsen Farmaceutica

Status and phase: Completed; Phase 3

Conditions: Postsurgical Pain; Third Molar Extraction

Treatments: Drug: Toragesic®; Drug: APSCTC; Drug: Tramal®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04647435

APS001/2020

Details and patient eligibility

About

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

Enrollment: 396 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

396 participants in 3 patient groups

APSCTC

Experimental group

Description:

Oral tablets every 6h for 3 days

Treatment:

Drug: APSCTC

Toragesic®

Active Comparator group

Description:

Oral tablets every 6h for 3 days

Treatment:

Drug: Toragesic®

Tramal®

Active Comparator group

Description:

Oral tablets every 6h for 3 days

Treatment:

Drug: Tramal®