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临床试验/NCT00855777
NCT00855777Unknown4 期

Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.

Universita di Verona0 个研究点目标入组 110 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
110
主要终点
analgesic efficacy

研究概览

简要总结

The aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar extraction pain. At this time, there are no data about the efficacy of etoricoxib for reducing pain following dental extraction.

This will be a single center, randomized, double-blind study, in which patients with moderate to severe pain following third molar extraction will be randomized to receive etoricoxib (120 mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen (1800 mg in 3 doses pro day for 3 days). Paracetamol plus codeine will be used as rescue medication. Pain assessment will be performed using a 11-point pain intensity scale (0 = no pain and 10 = worster pain) during the first 3 days after dental extraction. Patients will be enrolled 15 days before the dental extraction. During enrollment visit a complete clinical evaluation with particular attention for potential exclusion criteria (e.g. hypertension and cardiovascular risk factors) as well as blood analyses will be performed. A follow-up visit will be performed 15 days after the dental extraction. Tolerability will be assessed through recording of adverse events.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects with age > 18 years
  • in good health status (assessed in occasion of enrollment visit) without any major systemic illness
  • candidate to third molar extraction and presenting local pain within 2 hours after dental extraction

排除标准

  • patients with any major systemic illness
  • patients with a clinical history of drug abuse
  • patients with hypertension and/or a condition of increased cardiovascular risk
  • pregnant or lactating women
  • patients with a history of hypersensitivity/allergy to analgesic drugs, including classical NSAID or coxibs
  • patients with either high levels of liver enzymes (major of 1.5x the upper limit of reference interval) or of creatinine(major of 1.2x the upper limit of reference interval)
  • patients with either a history of peptic ulcer or of haemorrhagic diathesis
  • patients who can not ensure an adequate compliance for the study

研究组 & 干预措施

Etoricoxib

Experimental

Etoricoxib 120 mg/day x 3 days

干预措施: etoricoxib (Drug)

Ibuprofen

Active Comparator

Ibuprofen 1800 mg/day x 3 days

干预措施: ibuprofen (Drug)

结局指标

主要结局

analgesic efficacy

时间窗: 3 days

次要结局

  • side effects(3 days)

研究者

发起方
Universita di Verona
申办方类型
Other

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