Status:
COMPLETED
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
Lead Sponsor:
Laboratorios Liomont
Collaborating Sponsors:
Infinite Clinical Research, S.A. de C.V.
Conditions:
Acute Pain
Postoperative Pain
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
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 naproxe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05995912
Start Date
September 29 2021
End Date
October 14 2022
Last Update
October 10 2024
Active Locations (1)
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1
Oaxaca Site Management Organization
Oaxaca City, Mexico, 68000