NCT00353808终止2 期
An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Vital signs
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026.
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
- •Patients must have met the patient selection criteria for the preceding double-blind Protocol A6061026 and have completed the 16-week trial.
- •Patients at screening must have a score of >/=40mm on the pain visual analogue scale.
排除标准
- •Serious adverse event during the preceding double-blind Protocol A6061026 that was determined to be related to the trial medication by the Investigator.
- •Patient treatment compliance was less than 80% in the preceding double-blind Protocol A6061026.
研究组 & 干预措施
s, s reboxetine
Experimental
干预措施: [S,S]-Reboxetine (Drug)
结局指标
主要结局
Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events
次要结局
- Pain Visual Analogue Scale
- Patient Global Impression of Change
研究者
研究点 (1)
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