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

Primary Purpose

Acute Pain, Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
etoricoxib-tramadol
Naproxen
Tramadol
Sponsored by
Laboratorios Liomont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Etoricoxib-tramadol, Third molar extraction, Analgesia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Positive pregnancy test or lactating women. Positive rapid urine drug test.

Sites / Locations

  • Oaxaca Site Management Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Etoricoxib-Tramadol

Naproxen + Tramadol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain intensity difference (PID)
The difference in pain intensity at 1, 2, 3, 6, 12, 24, 48, and 72 hours after drug administration versus time 0 (baseline, before dosing)
Total pain relief (TOTPAR)
TOTPAR is a time-weighted measure of AUC or total area under the pain relief curve and is a summary measure that integrates serial assessments of a subject's pain over the duration of the study or in any time frime.
Trismus control
Measurement the difference of mouth opening (in mm) at baseline (before dosing) and at the end of the study (Day 7).
Adverse events
Characteristics and frequency of adverse events

Full Information

First Posted
August 1, 2023
Last Updated
August 10, 2023
Sponsor
Laboratorios Liomont
Collaborators
Infinite Clinical Research, S.A. de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05995912
Brief Title
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
Official Title
Efficacy and Safety of Etoricoxib-tramadol 120mg/100mg on Acute Pain After Impacted Lower Third Molar Extraction: A Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
August 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Liomont
Collaborators
Infinite Clinical Research, S.A. de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Postoperative Pain
Keywords
Etoricoxib-tramadol, Third molar extraction, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etoricoxib-Tramadol
Arm Type
Experimental
Arm Description
Etoricoxib-Tramadol 120mg/100mg tablet, once-daily, for 3 days
Arm Title
Naproxen + Tramadol
Arm Type
Active Comparator
Arm Description
Naproxen 220 mg tablet + Tramadol 50 mg capsule, twice a day, for 3 days.
Intervention Type
Drug
Intervention Name(s)
etoricoxib-tramadol
Intervention Description
Oral administration (with or without food)
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Oral administration (with or without food)
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Oral administration (with or without food)
Primary Outcome Measure Information:
Title
Pain intensity difference (PID)
Description
The difference in pain intensity at 4 h after drug administration versus time 0 (baseline, before dosing)
Time Frame
At 4 h (Day 0, postdosing) respect the baseline (Day 0, before dosing)
Secondary Outcome Measure Information:
Title
Pain intensity difference (PID)
Description
The difference in pain intensity at 1, 2, 3, 6, 12, 24, 48, and 72 hours after drug administration versus time 0 (baseline, before dosing)
Time Frame
At 1, 2, 3, 6, 12, 24, 48, and 72 hours postdosing respecto the baseline (Day 0, before dosing)
Title
Total pain relief (TOTPAR)
Description
TOTPAR is a time-weighted measure of AUC or total area under the pain relief curve and is a summary measure that integrates serial assessments of a subject's pain over the duration of the study or in any time frime.
Time Frame
At 4, 6, 12, 24, 48, 72 hours postdosing respect to the baseline (Day 0, before dosing)
Title
Trismus control
Description
Measurement the difference of mouth opening (in mm) at baseline (before dosing) and at the end of the study (Day 7).
Time Frame
At the end of the study (Day 7) respect to the baseline (Day 0, before dosing)
Title
Adverse events
Description
Characteristics and frequency of adverse events
Time Frame
From informed consent (Day -28) to the end of the study (Day 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Positive pregnancy test or lactating women. Positive rapid urine drug test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania A. Sibaja Ponce, M.D.
Organizational Affiliation
Oaxaca Site Management Organization, S.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oaxaca Site Management Organization
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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