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

NCT05995912 | Completed Phase 2

• 1 other identifier: LT-04-20
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Etoricoxib-tramadol; Third molar extraction; Analgesia

Outcome Measures

Primary Outcomes (1)

• Pain intensity difference (PID)

  The difference in pain intensity at 4 h after drug administration versus time 0 (baseline, before dosing)

  At 4 h (Day 0, postdosing) respect the baseline (Day 0, before dosing)

Secondary Outcomes (4)

• Pain intensity difference (PID)

  At 1, 2, 3, 6, 12, 24, 48, and 72 hours postdosing respecto the baseline (Day 0, before dosing)

• Total pain relief (TOTPAR)

  At 4, 6, 12, 24, 48, 72 hours postdosing respect to the baseline (Day 0, before dosing)

• Trismus control

  At the end of the study (Day 7) respect to the baseline (Day 0, before dosing)

• Adverse events

  From informed consent (Day -28) to the end of the study (Day 7)

Study Arms (2)

Etoricoxib-Tramadol

EXPERIMENTAL

Etoricoxib-Tramadol 120mg/100mg tablet, once-daily, for 3 days

Drug: etoricoxib-tramadol

Naproxen + Tramadol

ACTIVE COMPARATOR

Naproxen 220 mg tablet + Tramadol 50 mg capsule, twice a day, for 3 days.

Drug: Naproxen; Drug: Tramadol

Interventions

etoricoxib-tramadol DRUG

Oral administration (with or without food)

Etoricoxib-Tramadol

Naproxen DRUG

Oral administration (with or without food)

Naproxen + Tramadol

Tramadol DRUG

Oral administration (with or without food)

Naproxen + Tramadol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes aged from 18 to 40 years.
• Patients who agreed to participate in the study by signing the informed consent.
• Patients with indication for surgical extraction of impacted lower third molars according to the Pell and Gregory classification.
• Healthy subjects or with history of controlled chronic non-communicable diseases or that can be controlled prior to surgery, which, in the investigator's opinion, do not represent an additional risk for the patient.
• Patients who, at the investigator's discretion, meet personal and family conditions that allow them to properly comply with the activities described in the protocol and adherence to treatment.

You may not qualify if:

• Findings in the clinical history, vital signs, physical examination or laboratory studies suggesting abnormal conditions which represent a risk for subject's health at the investigator´s discretion.
• Hypersensitivity to any of the active ingredients and/or excipients of the investigational drugs.
• Patients with active peptic or gastroduodenal ulcer or diagnosis 30 days prior to signing the informed consent.
• Patients with history of allergic asthma reactions.
• Patients with severe hepatic dysfunction, classified as Child Pugh C or when being less, the investigator considers it an additional risk for patients.
• Patients with a creatinine clearance \<30 mL/min.
• Patients with coagulation disorders.
• Patients with Systemic Lupus Erythematosus.
• Patients with congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease who have recently (3 months) undergone coronary artery bypass grafting or angioplasty procedures.
• Patients at high risk of acute cardiovascular events (intense smoking, hypertension or uncontrolled diabetes mellitus).
• Patients with a history of systemic neoplastic diseases or under treatment with chemotherapy.
• Patients with a history of illicit drug abuse or addiction to alcohol or tobacco.
• Patients with monoamine oxidase inhibitors (MAOIs) treatment or during the last 2 weeks prior to the study drug administration.
• Patients with opioid analgesics, neuromodulators, or long-acting NSAIDs therapy who, according to medical criteria, cannot carry out a withdrawal scheme for at least five half-lives prior to surgery.
• Patients with history of seizures or who are under treatment with medications that reduce the seizure threshold and who, according to medical criteria, cannot carry out a withdrawal scheme within 30 days prior to surgery.

Sponsors & Collaborators

• Laboratorios Liomont: lead
• Infinite Clinical Research, S.A. de C.V.: collaborator

Study Sites (1)

Oaxaca Site Management Organization

Oaxaca City, 68000, Mexico

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Agnosia

Interventions

Naproxen; Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Tania A. Sibaja Ponce, M.D.

  Oaxaca Site Management Organization, S.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 16, 2023
• Study Start: September 29, 2021
• Primary Completion: August 18, 2022
• Study Completion: October 14, 2022
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)