ISRCTN33347454已完成不适用
A randomised, double-blind, crossover comparison of the efficacy and safety of study drug 017 and placebo in patients with neuropathic pain due to diabetic neuropathy (DN) or post-herpetic neuralgia (PHN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •For diabetic neuropathy patients:
- •1. Stable glycaemic control
- •2. Patients with pain in the lower extremities on a daily basis and one or more signs or symptoms of peripheral neuropathy not attributable to any other cause
- •3. Patients with absent or decreased ankle reflexes and loss of perception of 128 Hz vibration of the great toe
- •For post-herpetic neuralgia patients:
- •1. Primary diagnosis of PHN defined by pain for at least three months after healing of a herpes zoster skin rash
- •For all patients:
- •1. Male or non-pregnant females at least 18 years of age
- •2. Patients who answer yes to at least four items on the the neuropathic pain diagnostic questionnaire (DN4)
- •3. Patients whose pain has been of moderate intensity on most days for at least three months
- •4. Patients who have required the use of analgesic medication for at least three months
排除标准
- •1. Patients who do not have stable glycaemic control (HbA1c greater than 2 x normal) or whose anti-diabetic therapy is likely to require adjustment during the study
- •2. Patients with peripheral neuropathy attributable to other causes
- •3. Significant pain of other origin that may obscure the assessment of efficacy
- •4. Patients whose opioid requirement may exceed eight tablets of acetaminophen plus codeine (300/30 mg) or analgesic equivalent per day
- •5. Patients with true allergy to acetaminophen or any opioid, sufficient that therapy is contraindicated
- •6. Patients with any of the following medical conditions:
- •6.1. Active, severe psychiatric disorder, including severe depression
- •6.2. Postural hypotension
- •6.3. Clinically significant hepatic dysfunction (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [Alk Phos] greater than 2 x normal)
- •6.4. Symptomatic coronary artery peripheral vascular disease
- •6.5. Intermittent claudication
- •6.6. Brittle diabetes
- •6.7. Low serum cobalamin (vitamin B12)
- •6.8. Abnormal serum folic acid levels
- •6.9. Colostomy, ileostomy or shortened gastrointestinal (GI) transit time
- •6.10. Active or recent peptic ulcer or gastrointestinal (GI) inflammatory disease
- •6.11. Epilepsy, history of seizures or recognised risk for seizure
- •6.12. Any condition that may adversely affect patient safety or obscure assessment of efficacy
- •7. Patients receiving any of the following medications:
- •7.1. Monoamine oxidase inhibitors
- •7.2. Carbamazepine
- •7.3. Quinidine
- •7.4. Selective serotonin reuptake inhibitors
- •7.5. Serotonin norepinephrine reuptake inhibitors
- •7.6. Neuroleptics
- •7.7. Warfarin
- •7.8. Digoxin
- •8. Patients who have received an investigational drug within the previous month
- •9. Patients with a known or suspected history of drug or alcohol abuse
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