EUCTR2009-012713-22-AT进行中（未招募）不适用
Randomized Double-blind Study Comparing the Efficacy of Duloxetine with Placebo in Patients with Chronic Low Back Pain
Medizinische Universität Wien, Univ. Klinik für Anästhesie, Allg. Intensivmedizin u Schmerztherapie0 个研究点开始时间: 2010年4月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18-65 years
- •Low back pain ( below L1)
- •Chronic pain, >6 months
- •Visual Analogue Scale (VAS) = 5
- •Back pain with radicular component defined as pain with a burning, tingling sensation within the anatomic distribution of the nerve root and diagnosed by painDETECT questionnaire
- •Previous diagnostic imaging showing affliction of nerve roots
- •Failed back surgery
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current mood disorder (dysthymia, bipolar mood disorder)
- •Major Depression > 12 months (Beck Depression Inventory Score = 18)
- •History of a psychoactive substance use disorder within the preceding 12 months
- •Major coexisting medical illness (e.g. severe heart failure, pulmonary
- •hypertension, renal insufficiency)
- •Acute myocardial infarction
- •uncontrolled hypertension
- •Prostate hyperplasia
- •History of convulsion
- •Pregnancy; women of childbearing age will be required to use contraceptives during the duration of the study
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Allergy of study medication
- •Use of the following medication:
- •-opioids except for tramadol,
- •-benzodiazepines other than indicated at low doses for sleep disorders
- •-antineuropathic medication including except for that specified in the study protocol
- •-muscle relaxants
- •-antidepressants other than indicated at low doses for sleep disorders
- •-NSAID, Paracetamol
- •-non-selective MAO-Inhibitors
- •-Fluvoxamine, Ciprofloxacin, Enoxacin
- •-Selective Serotonin-reuptake Inhibitors (SSRI)
- •Impaired kidney function (Creatinine > 1.5mg/dl)
- •Impaired hepatic function (GOT, GPT >2 fold standard levels)
- •Patients who are not able to understand the study measures and are not able to complete pain assessment forms.
研究者
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