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

NCT05995912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-10-10

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Infinite Clinical Research, S.A. de C.V.

    collaborator INDUSTRY

  • Laboratorios Liomont

    lead INDUSTRY

Principal Investigators

  • Tania A. Sibaja Ponce, M.D. · Oaxaca Site Management Organization, S.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2022-08-18
Completion
2022-10-14

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995912 on ClinicalTrials.gov