NCT00772980已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 54
- 主要终点
- TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 aged 18 to 75 years with a clinical diagnosis of first onset, persistent (i.e. tinnitus sghould never be absent for >24 hours in a row), subjective, uni-or bilateral tinntius present for at least 3 months but not more than 12 months.
排除标准
- •Clinical diagnosis of intermittent or pulsatile tinnitus
- •Patients who have tinnitus as a concomitant symptom of an otological/neurological disease(such as otitis media, Meniére´s disease, otosclerosis, etc.)
研究组 & 干预措施
1
Experimental
Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
干预措施: Neramexane mesylate (Drug)
2
Placebo Comparator
Drug: Placebo Double-blind treatment period of 17 weeks placebo
干预措施: Placebo (Drug)
结局指标
主要结局
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment
时间窗: Screening, Baseline, week 5, 13, 17
次要结局
- TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics(29 weeks)
- safety parameters(29 weeks)
研究者
研究点 (54)
Loading locations...
相似试验
已完成
3 期
Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective TinnitusSubjective TinnitusNCT00955799Merz Pharmaceuticals GmbH455
已完成
3 期
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective TinnitusSubjective TinnitusNCT00739635Merz Pharmaceuticals GmbH411
已完成
2 期
Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired NystagmusNystagmus, Congenital IdiopathicNystagmus, AcquiredNCT00661440Merz Pharmaceuticals GmbH48
已完成
3 期
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)Ulcerative ColitisNCT02522767Ferring Pharmaceuticals228
进行中（未招募）
1 期
Efficacy and safety of neramexane mesylate in congenital idiopathic nystagmus and acquired nystagmus: a randomized, double-blind, placebo-controlled, single center, proof of concept study using a two-period cross-over design.Congenital idiopathic nystagmus and acquired nystagmusMedDRA version: 9.1 Level: LLT Classification code 10029864 Term: NystagmusMedDRA version: 9.1 Level: LLT Classification code 10029867 Term: Nystagmus congenitalEUCTR2007-002595-34-GBMerz Pharmaceuticals GmbH48