Efficacy and Safety of Etoricoxib-tramadol 120mg/100mg on Acute Pain After Impacted Lower Third Molar Extraction: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Pain intensity difference (PID)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Etoricoxib-Tramadol
Etoricoxib-Tramadol 120mg/100mg tablet, once-daily, for 3 days
干预措施: etoricoxib-tramadol (Drug)
Naproxen + Tramadol
Naproxen 220 mg tablet + Tramadol 50 mg capsule, twice a day, for 3 days.
干预措施: Naproxen (Drug)
Naproxen + Tramadol
Naproxen 220 mg tablet + Tramadol 50 mg capsule, twice a day, for 3 days.
干预措施: Tramadol (Drug)
结局指标
主要结局
Pain intensity difference (PID)
时间窗: At 4 h (Day 0, postdosing) respect the baseline (Day 0, before dosing)
The difference in pain intensity at 4 h after drug administration versus time 0 (baseline, before dosing)
次要结局
- Adverse events(From informed consent (Day -28) to the end of the study (Day 7))
- 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))