Efficacy of Etoricoxib in Patients With Neuropathic Pain With and Without Peripheral Hyperalgesia - A Prove of Concept Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo
研究概览
简要总结
The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The investigators assume that patients with neuropathic pain will have greater pain relief then patients on placebo.
详细描述
Animal experiments analysing anti-hyperalgesic effects of Coxibs show inconsistent results due to different used dosages and varying different pain models. Theoretical the use of NSAIDs is rational, particularly of Coxibs as a part of the neuropathic pain management. But in the newest topical review, there is no valid information available about the effectiveness of these drugs in human neuropathic pain models or in patients with different underlying mechanism, e.g. with or without hyperalgesia.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years 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:
- •signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold)
- •without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold)
- •Patients of both gender
- •Signed consent form
- •Patients with the ability to understand and follow the instructions of the doctor
排除标准
- •Excluded will be patients 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:
- •Hypersensitivity to the active substance or to any of the excipients.
- •Active peptic ulceration or active gastrointestinal (GI) bleeding.
- •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.
- •Pregnancy and lactation
- •Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
- •Estimated renal creatinine clearance <30 ml/min.
- •Inflammatory bowel disease.
- •Congestive heart failure (NYHA II-IV).
- •Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
- •Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
- •Intake of one of the following drugs (current or in the last 3 days)
- •selective-serotonin-reuptake-inhibitor
- •cetoconazole
- •rifampicin
- •phenytoin
- •carbamazepine
- •dexamethasone or other systemic corticoids
- •traditional nonsteroidal antiphlogistics
- •cyclooxygenase-inhibitors
- •immunosuppressives
- •TNF-α-inhibitors
研究组 & 干预措施
etoricoxib, peripheral hyperalgesia
14 patient with neuropathic pain and peripheral hyperalgesia get etoricoxib 90mg for 8 days
干预措施: Etoricoxib (Drug)
etoricoxib, no peripheral hyperalgesia
14 patients with neuropathic pain without peripheral hyperalgesia get etoricoxib 90mg for 8 days
干预措施: Etoricoxib (Drug)
placebo, peripheral hyperalgesia
14 patients with neuropathic pain with peripheral hyperalgesia get placebo for 8 days
干预措施: placebo (Drug)
placebo, no peripheral hyperalgesia
14 patients with neuropathic pain without peripheral hyperalgesia get placebo for 8 days
干预措施: placebo (Drug)
结局指标
主要结局
Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo
时间窗: 12 month
次要结局
- Reduction of the average on-going pain(12 month)
研究者
Christoph Maier, Prof. Dr.
Prof. Dr.
Ruhr University of Bochum