A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Average daily pain intensity (BPI Questions 3,4,5, and 6)
研究概览
简要总结
Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator)
- •Patients with PHN must have had pain >3 months after rash healing
- •Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
- •Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria
- •Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration
- •Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration
- •Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration
- •Reached an average daily pain rating during the baseline week of pain ratings greater than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI)
- •Had never received an analgesic regimen that contained lidocaine or gabapentin
排除标准
- •Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study
- •Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine
- •Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
研究组 & 干预措施
placebo capsules + placebo patch
Placebo to match lidocaine patch; up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing
干预措施: Placebo Capsules + Placebo Patch (Drug)
placebo capsules + Lidoderm patch (Lidocaine Group)
Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing
干预措施: Placebo capsules + Lidoderm® (Drug)
Gabapentin capsules 1800 mg/day + placebo patch
Gabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain
干预措施: Gabapentin + Placebo (Drug)
Gabapentin capsules 1800 mg/day + placebo patch
Gabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain
干预措施: Gabapentin 300 mg capsules 1800 mg/day + placebo patch (Drug)
Gabapentin capsules 1800 mg/day + Lidoderm patch
Gabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain
干预措施: Gabapentin + Lidoderm® (Drug)
Gabapentin capsules 1800 mg/day + Lidoderm patch
Gabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain
干预措施: Gabapentin 1800 mg/day + Lidoderm patch (Drug)
结局指标
主要结局
Average daily pain intensity (BPI Questions 3,4,5, and 6)
时间窗: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)
次要结局
- Investigator and Patient Global Impression of Change
- Pain Quality Assessment Scale (PQAS)
- Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)
- Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination
- Allodynia Testing
- QoL; Symptom Checklist, pain interference with QoL