ACTRN12609000647235进行中（未招募）3 期
A Multicentre, Randomised, Double-Blind, Parallel Group Comparison Of The Efficacy And Safety Of Transdermal Buprenorphine (Norspan'registered trade mark' Buprenorphine transdermal system [BTDS]) And Placebo In Patients With Diabetic Peripheral Neuropathic Pain.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients must have documented diagnosis of Type 1 or Type 2 diabetes mellitus for the last 6 months with stable glycaemic control for three months as assessed by the Investigator and a glycosylated haemoglobin (HbA1c) of <= 8.5% and without any major swings in blood glucose levels associated with frequent hypoglycaemia may enter the study.
- •Patients must have a history of diabetic peripheral neuropathic pain (DPNP) attributable to diabetic sensorimotor polyneuropathy on clinical grounds.
- •Patients must have a pain intensity of at least moderate intensity (NRS >= 4/10) at the screening visit (WkS).
排除标准
- •Patient has other cause of neuropathy or lower extremity pain which may confound assessment of DPNP.
- •Patient has clinical evidence of active infection at the site of DPNP.
- •Patient has undergone prior neurolytic treatment (nerve destructive procedures by application of chemicals, heat or cold), intrathecal pump insertion, or spinal cord stimulation for DPNP or other lower limb symptomatology, or has had somatic or sympathetic nerve blocks within the last six months for DPNP or other lower limb symptomatology.
- •Patient has symptomatic Peripheral Vascular Disease (PVD).
研究者
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