NCT00904020已完成4 期
A Prospective, Open-Label, Multicenter Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain
Endo Pharmaceuticals0 个研究点目标入组 107 人开始时间: 2002年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 主要终点
- Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)
研究概览
简要总结
Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Were currently receiving an analgesic regimen that contained gabapentin
- •Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
- •Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of >4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory [BPI] within 24 hours prior to the screening visit
- •For diabetic patients, had a hemoglobin A1c level <0.13 (normal range, 0.047-0.064)
排除标准
- •Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
- •Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
- •Had received trigger point injections within 14 days prior to study entry
- •Had received Botox injections within 3 months prior to study entry
- •Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
- •Were taking Class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
研究组 & 干预措施
(1) Lidoderm
Experimental
(1) Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.
干预措施: Lidoderm (Drug)
结局指标
主要结局
Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)
时间窗: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
次要结局
- Pain quality using the Neuropathic Pain Scale (NPS)(Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14))
- Extent of numbness at the site of pain using the Numbness Questionnaire(Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14))
- Patient Global Assessment of Pain Relief(Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14))
- QoL: Patient Global Assessment of Patch Satisfaction(Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14))
- Investigator and Patient Global Impression of Change(Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14))
- Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments(Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14))
- QoL: Pain interference (BPI Question 9)(Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14))
研究者
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