NCT05995912

Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain

Efficacy and Safety of Etoricoxib-tramadol 120mg/100mg on Acute Pain After Impacted Lower Third Molar Extraction: A Double Blind Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Laboratorios Liomont · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of the present phase IIb clinical trial was to compare the safety and efficacy of the fixed-dose combination etoricoxib-tramadol 120mg/100mg tablet (once a day, for three days) versus naproxen 220mg tablet plus tramadol 50 mg capsule in patients with acute postoperative pain after impacted third molar extraction. The main research question was: Is the analgesic efficacy of etoricoxib-tramadol 120mg/100mg tablet non-inferior to naproxen 220 mg tablet + tramadol 50 mg capsule in a clinical model of moderate to severe acute pain? After informed consent, patients were randomly assigned to one of the two arms: test product (etoricoxib-tramadol 120mg/100mg tablet) or active comparator (naproxen 220mg tablet + tramadol 50 mg capsule). After surgery, patients were requested to start the treatment with study drugs (test product was administered once daily for three days; meanwhile reference drug was administered twice a day for three days). Investigators compared the effects of both treatments on pain intensity at different time frames using the visual analogue scale. Furthermore, the safety of investigational drugs was assessed during the study.

Conditions

• Acute Pain
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	etoricoxib-tramadol	Oral administration (with or without food)
DRUG	Naproxen	Oral administration (with or without food)
DRUG	Tramadol	Oral administration (with or without food)

Timeline

• Start date: 2021-09-29
• Primary completion: 2022-08-18
• Completion: 2022-10-14
• First posted: 2023-08-16
• Last updated: 2024-10-10

Locations

1 site across 1 country: Mexico