CTRI/2011/07/001905招募中3 期
A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (Protocol A0081224) - Not applicable
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
- •2.At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
- •3.At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
- •4.Male or female of any race, at least 18 years of age, and using appropriate methods of contraception
- •Kindly note that there is no upper limit for inclusion criteria in the trial.
排除标准
- •1. Creatinine clearance lessthan 30 mL/min (estimated from serum creatinine).
- •2.Skin conditions in the affected dermatome that could alter sensation
- •3.Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin
研究者
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