Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
Phase 3
Completed
- Conditions
- Postsurgical PainThird Molar Extraction
- Interventions
- Registration Number
- NCT04647435
- Lead Sponsor
- Apsen Farmaceutica S.A.
- Brief Summary
The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 396
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APSCTC APSCTC Oral tablets every 6h for 3 days Toragesic® Toragesic® Oral tablets every 6h for 3 days Tramal® Tramal® Oral tablets every 6h for 3 days
- Primary Outcome Measures
Name Time Method At least 50% of maximum pain relief score (TOTPARmax) Change from Baseline to 6 hours
- Secondary Outcome Measures
Name Time Method Adverse events incidence and classification During treatment
Trial Locations
- Locations (1)
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
🇧🇷Valinhos, São Paulo, Brazil