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临床试验/NCT00257270
NCT00257270已完成2 期

The Effect of Gabapentin on the Sensation and Impact of Tinnitus

Tinnitus Research Consortium0 个研究点目标入组 40 人开始时间: 2003年8月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
主要终点
Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.

研究概览

简要总结

This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations: Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The hypothesis was that gabapentin would decrease both subjective and objective features of tinnitus in the trauma group, but would be less effective in the non-trauma group.'

详细描述

Methods. A prospective, placebo-controlled, single-blind study of the effect of gabapentin on tinnitus was employed. Audiograms and personal histories were used to categorize tinnitus etiology as either secondary to acoustic trauma, or not associated with acoustic trauma. Participants were restricted to those with moderate-to-severe tinnitus for at least one year. All participants received gabapentin in a graduated ascending-descending dose series over 20 weeks (peak dose of 2400 mg/day).

Results. There was a significant improvement in tinnitus annoyance for the trauma group (p = 0.05). Other subjective aspects of tinnitus were not significantly affected in either group. Between-subject variability of therapeutic response was considerable. Nevertheless, considering subjective loudness ratings, 4/19 non-trauma participants, and 6/20 trauma participants showed an improvement of 20 percent or better. Considering psychoacoustic loudness estimates, 4/19 non-trauma and 6/20 trauma participants showed a 15 dB (HL) improvement. Evenly dividing each group into high and low responders revealed significant improvement in loudness at 1800 and 2400 mg/day for the trauma high-response subgroup (p = 0.007). No significant improvement was obtained for other subgroups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single

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

入选标准

  • non-pulsatile tinnitus present > 1 year
  • Tinnitus Handicap Questionnaire score > 30
  • ability to perform psychophysical matching procedure

排除标准

  • evidence of depression
  • renal insufficiency
  • conductive hearing loss

结局指标

主要结局

Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.

Psychophysical loudness match of tinnitus to broad band noise and pure tones.

The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.

次要结局

  • Quality of Life survey (SF36-QOL)

研究者

发起方
Tinnitus Research Consortium
申办方类型
Other

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