Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by the patient's scoring it from one to ten, before and after prescribing Gabapentin.
研究概览
简要总结
The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus.
详细描述
Tinnitus is the perception of sound in the absence of acoustic stimulation. It can be subjective or objective. .
Despite numerous researches,no effective treatment for people who suffer from tinnitus has yet been stablished.
As there are many evidences suggesting that loss of inhibition in the central nervous system may be responsible for many aspects of auditory dysfunction,including tinnitus; and as Gabapentin (Neurontin), a gama-aminobutyric acid (GABA) analogue, is an effective medication in conditions where inhibition in the CNS is impaired; we guess that Gabapentin might be useful for treating idiopathic subjective tinnitus.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with subjective idiopathic tinnitus
排除标准
- •tinnitus with known underlying cause
- •pregnant women and patients younger than 18 or older than 75 years
- •patients with impaired renal function
研究组 & 干预措施
1
Randomly,half of the subjects are given Gabapentin.
干预措施: Gabapentin (Drug)
2
Randomly,half of the subjects receive placebo.
干预措施: placebo (Drug)
结局指标
主要结局
Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by the patient's scoring it from one to ten, before and after prescribing Gabapentin.
时间窗: two months
次要结局
- Relieve of complications of tinnitus, such as sleep difficulties.(two months)