NCT00317850终止2 期
Gabapentin for the Relief of Idiopathic Subjective Tinnitus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 160
- 主要终点
- Tinnitus Handicap Inventory Score from Baseline to Week 8
研究概览
简要总结
The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory were enrolled.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, between the ages of 18 and 70
- •Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month's duration or greater
- •Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.
排除标准
- •The symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. Patients who have used these drugs within 30 days of screening will not be enrolled.
- •Impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male Ccr = (140 -age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter); and adult female Ccr = [(140 - age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter)] X 0.85,whereCcr indicates creatinine clearance.
- •Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone
- •Patients with any serious or unstable medical or psychiatric condition.
- •Patients whose ability to give informed consent is in question.
结局指标
主要结局
Tinnitus Handicap Inventory Score from Baseline to Week 8
次要结局
- Brief Symptom Inventory Score from Baseline to Week 8
- Beck Depression Inventory Score from Baseline to Week 8
- Epworth Sleepiness Scale Score from Baseline to Week 8
研究者
Jay F. Piccirillo, MD
Professor of Otolaryngology, Director of Clinical Outcomes Research Office
Washington University School of Medicine
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