A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Postherpetic Neuralgia and Post-traumatic Neuralgia, Followed by a Double Blind Safety Extension and an Open-label Safety Extension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 112
- 主要终点
- The daily evening assessment of average pain intensity
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of JNJ-42160443 in the treatment of moderate to severe neuropathic pain in patients with a diagnosis of postherpetic neuralgia and post-traumatic neuralgia.
详细描述
The current study is a randomized (study drug assigned by chance), double-blind (neither the study doctor nor the patient knows the name of the assigned drug), placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and tolerability of JNJ-42160443 in patients with postherpetic neuralgia and post-traumatic neuralgia, followed by a double blind extension and an open-label (study doctor and patient knows the name of the study drug) extension. This study will evaluate the safety and effectiveness of JNJ-42160443 in the treatment of patients with moderate to severe, chronic, neuropathic pain that is not controlled with or without standard pain therapy and who have a diagnosis of postherpetic neuralgia (PHN) or post-traumatic neuralgia. The total duration of the study will be approximately 130 weeks (i.e., includes screening phase, 12-week double-blind efficacy phase, double-blind safety extension phase, and the open-label safety extension phase). During the 12 week treatment and 40 week double-blind extension phases, PHN patients will receive Placebo, JNJ 42160443 1, 3, or 10 mg and post-traumatic neuralgia patients will receive placebo or JNJ-42160443 10 mg; all doses will be given as a single, subcutaneous (under the skin) (SC) injection every 28 days. During the 52-week open-label extension phase, all patients will receive a single SC injection of JNJ-42160443 up to 10 mg every 4, 8, or 12 weeks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with postherpetic neuralgia or post-traumatic neuralgia and who have chronic neuropathic pain (pain persistent for > 6 months) that is moderate to severe; Currently taking pain medication but are not adequately controlled by standard of care or are not currently taking pain medications because intolerable to, or not willing to use, standard of care.
排除标准
- •History of a separate pain condition (e.g., joint osteoarthritis) that is more severe than pain due to diagnosis of PHN or post-traumatic neuralgia
- •Patients with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I
- •Patients with lumbar-sacral radiculopathy, failed low-back surgery, or spinal cord injury
- •Patient whose nerve injury or pain is expected to recover in the next 4 months
- •Patients with evidence of another neuropathic pain not under study, such as pain resulting from diabetic painful neuropathy, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection
- •Other peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms that is not related with the PHN or post-traumatic neuralgia under the study
- •Women who are pregnantHistory of a separate pain condition (e.g., joint osteoarthritis) that is more severe than pain due to diagnosis of PHN or post-traumatic neuralgia; Patients with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I; Patients with lumbar-sacral radiculopathy, failed low-back surgery, or spinal cord injury; Patient whose nerve injury or pain is expected to recover in the next 4 months; Patients with evidence of another neuropathic pain not under study, such as pain resulting from diabetic painful neuropathy, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection; Other peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms that is not related with the PHN or post-traumatic neuralgia under the study; Women who are pregnant or breast-feeding; Type I or Type II diabetes.
研究组 & 干预措施
001
JNJ-42160443 SC injection (1 3 or 10 milligrams) once every 28 days
干预措施: JNJ-42160443 (Drug)
002
Placebo SC injection once every 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
The daily evening assessment of average pain intensity
时间窗: Baseline (7 days before randomization) and last 7 days of the 12-week treatment phase
次要结局
- Neuropathic pain symptom inventory(Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9))
- Patient Global Impression of Change(Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9))
- Brief Pain Inventory(Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9))
- Pain at its worst(Daily for 12 weeks)