Wirksamkeit von Etoricoxib bei Patienten mit neuropathischen Schmerzen mit und ohne peripherer Hyperalgesie(Efficacy of etoricoxibe in patients with neuropathic pain with and without peripheral hyperalgesia)

BG university hospital Bergmannsheil GmbH0 个研究点目标入组 65 人开始时间: 2009年12月28日最近更新: 2012年3月19日

试验速览

暂无简介。

•Included will be patients 18 years or older either genera with
•-persistent moderate or severe pain (> 4 on NRS (1..10)) at rest (average of three daily assessments using a diary for at least two days) .
•-neuropathic pain associated with a clinical and neurologically proven peripheral nerve injury, radiculopathy, postherpetic neuralgia or polyneuropathy or CRPS
•-one of the two following QST phenotypes at the baseline assessment:
•A.signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold)
•B.without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold)
•Each diagnosis will be confirmed by a pain specialist and a neurologists with clinical and neurographic measuring, including standardized QST
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Excluded will be patients with central pain, Parkinson’s disease or a history of cerebral vascular insult or nerve injury.
•Excluded will be also all patients with contradictions for the use of Etoricoxib:
•1.Hypersensitivity to the active substance or to any of the excipients.
•2.Active peptic ulceration or active gastrointestinal (GI) bleeding.
•3.Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetyl-salicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
•4.Pregnancy and lactation
•5.Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score =10).
•6.Estimated renal creatinine clearance <30 ml/min.
•7.Inflammatory bowel disease.
•8.Congestive heart failure (NYHA II-IV).
•9.Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
•10.Established ischemic heart disease, peripheral arterial disease, and/or cere-bro-vascular disease.
•Intake of one of the following drugs (current or in the last 3 days)
•o selective-serotonin-reuptake-inhibitor
•o cetoconazole
•o rifampicin
•o phenytoin
•o carbamazepine
•o dexamethasone or other systemic corticoids
•o traditional nonsteroidal antiphlogistics
•o cyclooxygenase-inhibitors
•o immunsupressives
•o TNF-a-inhibitors

发起方

BG university hospital Bergmannsheil GmbH