NCT00570310已完成1 期
A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- Daily Evening Patient Reported Pain Intensity Scores
研究概览
简要总结
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
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
- •Patient has moderate to severe nerve pain due to one of the following conditions: Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy
- •Patient is able to complete questionnaires in either English or Spanish
- •Patient is at least 18 years of age
排除标准
- •Patient is either pregnant or breastfeeding
- •Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)
- •Patient has a history of congestive heart failure
- •Patient has a seizure disorder
- •Patient has a history of drug and/or alcohol abuse within the past 1 year
- •Patient failed treatment due to lack of pain relief with more than three drugs for nerve pain
- •Patient has had cancer (except basal cell carcinoma) within the past two years
- •Patient anticipates the need for surgery while participating in the study
- •Patient has a reported history of hepatitis B, C, or HIV infection
- •Patient has another type of pain that is more painful than the nerve pain
- •Patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder
- •Patient is involved in litigation or receives worker's compensation related to nerve pain
研究组 & 干预措施
B
Placebo Comparator
Patients in Group B will be treated with placebo.
干预措施: Comparator: Placebo (unspecified) (Drug)
A
Active Comparator
Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.
干预措施: Comparator: pregabalin (Drug)
结局指标
主要结局
Daily Evening Patient Reported Pain Intensity Scores
时间窗: Baseline and 6 Weeks
Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)
次要结局
- 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study(6 Weeks)
研究者
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