NCT00644748已完成4 期
An Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点目标入组 95 人开始时间: 2003年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change from baseline Mean Pain Score
研究概览
简要总结
The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed.
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
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable Diabetes Mellitus 1 or 2
- •Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks
- •No clinically significant motor deficits
- •Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea
排除标准
- •Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin
- •Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety
研究组 & 干预措施
Gabapentin group
Experimental
干预措施: gabapentin (Drug)
结局指标
主要结局
Change from baseline Mean Pain Score
时间窗: Endpoint
次要结局
- Change from baseline Mean Pain Score(Weekly)
- Change from baseline Mean Pain Interference with Sleep Score(Weekly and Endpoint)
- Global Change Impression from the Patient's Point of View(Endpoint)
- Change from baseline in quality of life(Endpoint)
- Proportion of responding patients(Endpoint)
- Global Change Impression from the Physician's Point of View(Endpoint)
- Change from baseline in the 5 sub-scores of the McGill Reduced Pain Questionnaire: the sensory score, the affective score, the total score for pain descriptors, a visual analogue scale, and a scale of Present Pain Intensity(Endpoint)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of Gabapentin in Diabetic Peripheral NeuropathyDiabetic Peripheral NeuropathyNCT00712439Depomed147
已完成
3 期
Gabapentin for the Treatment of Hot Flashes in Menopausal WomenHot FlashesMenopauseNCT00112138North Toronto Primary Care Research Network200
已完成
3 期
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional SleeplessnessTransient InsomniaNCT00666575Pfizer's Upjohn has merged with Mylan to form Viatris Inc.2,105
终止
4 期
Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg SyndromeRestless Leg SyndromeNCT02117076Theresa Zesiewicz, MD5
已完成
4 期
Study of Efficacy of Gabapentin in Therapy of Bronchial AsthmaBronchial AsthmaNCT00153283Centre of Chinese Medicine, Georgia68