A Prospective, Open-label Trial of Lidoderm® (Lidocaine Patch 5%)in Painful Diabetic and Idiopathic Neuropathy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Mean change from baseline to Week 3 in average pain intensity as measured from patient diaries using Brief Pain Inventory Question 5.
研究概览
简要总结
Patients with Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with dynamic allodynia of the lower extremities, patients with Type I or II diabetes and pain distal symmetric sensorimotor polyneuropathy with no dynamic allodynia of the lower extremities, or patients with idiopathic distal predominantly sensory neuropathy participated in a Phase IV clinical trial to assess the efficacy of lidocaine patches in treating painful diabetic neuropathy or idiopathic distal sensory neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At Sites 1, 2, and 3 - Had painful diabetic polyneuropathy of 3 or more months duration
- •At Site 1 only - Had clinical signs and symptoms of distal predominantly sensory polyneuropathy of 3 or more months duration. Diagnosis of predominantly sensory polyneuropathy were to be confirmed by either nerve conduction studies (large fiber sensory or sensorimotor axonal neuropathy) or by abnormal epidermal innervations on punch skin biopsy (distal leg/proximal thigh) (Herrmann et al., 1999; Holland et al., 1997)
- •Had an average daily pain rating for the baseline week of pain ratings equal to 4 or greater on the 0 to 10 numerical pain rating scale
- •Had at least 2 hours of moderate or severe pain intensity due to polyneuropathy daily in the immediately prior 3-month period
- •Were using stable analgesic drug therapy for at least 1 week (regimen and dosages) prior to screening visit, with the exception of acetaminophen and lidocaine for patients undergoing a punch skin biopsy
排除标准
- •Had prior treatment with topical lidocaine, except for use with the punch skin biopsy procedure
- •Were currently under treatment with Class I antiarrhythmic agents (such as tocainide and mexiletine)
- •Had any other pain more severe than the painful diabetic or idiopathic neuropathy
- •Had open skin lesions in the area where the lidocaine patches were to be applied
研究组 & 干预措施
(1) Lidoderm
(1)Commercially available Lidoderm® (lidocaine patch 5%), up to four patches applied topically 18 hours on, 6 hours off per day to the area of maximal peripheral neuropathic pain
干预措施: Lidoderm (Drug)
结局指标
主要结局
Mean change from baseline to Week 3 in average pain intensity as measured from patient diaries using Brief Pain Inventory Question 5.
时间窗: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
次要结局
- McGill Pain Questionnaire(Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56))
- Other Pain Questions in BPI(Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56))
- Weekly pain intensity/relief measures(Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56))
- Pain duration using questions that assess duration and frequency of pain(Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56))
- Assessment of allodynia(Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56))
- Neuropathy Pain Scale(Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56))
- Assessment of safety was based on AEs, skin assessment, physical examination, vital signs, clinical laboratory data, and plasma lidocaine levels(Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56))