Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- ASHA Shift Ear (Left)
研究概览
简要总结
This prospective study is a randomized, double-blind, placebo-controlled Phase 3 clinical trial of oral D-methionine (D-met) to reduce noise-induced hearing loss (NIHL) and tinnitus. The goal of the study is to develop a safe, oral pharmacological agent to augment physical hearing protectors for noise exposures that exceed the protective capabilities of ear plugs and/or muffs. The study population is a cohort of Drill Sergeant (DS) instructor trainees during and 22 days after their 11 day weapons training. The primary objective of this study is to determine the efficacy of D-met in preventing NIHL or reducing tinnitus secondary to a minimum of 500 rounds of M-16 weapons training occurring over an 11 day period.
详细描述
Hearing loss can render a soldier less able to detect and identify the enemy, less able to understand commands, particularly in background noise typical on the battlefield, and may permanently reduce quality of life. In some cases, hearing loss may preclude redeployment or result in less optimal job assignment. Currently, no FDA approved pharmacological prevention exists for noise-induced hearing loss (NIHL). We have documented in animal studies that administration of D-methionine (D-met) can reduce or prevent NIHL. We now need to determine if it has similar efficacy in humans. Although we have not yet tested D-met on protection from noise-induced tinnitus in animals, this clinical trial would provide us the opportunity to also test for protection from noise induced tinnitus simultaneously.
Objective Hypotheses:
Primary Hypothesis: Administration of oral D-methionine prior to, during and 4 days post-weapons training will reduce or prevent permanent noise-induced hearing loss.
Secondary Hypothesis: Administration of oral D-methionine prior to, during and 4 days post-weapons training will reduce or prevent noise-induced tinnitus.
Specific Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.
干预措施: Placebo (Drug)
D-methionine, oral liquid suspension
D-methionine liquid suspension also contains sorbitol, orange flavor and purified water Intervention: Drug: D-methionine, oral liquid suspension.
干预措施: D-methionine (Drug)
结局指标
主要结局
ASHA Shift Ear (Left)
时间窗: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Either)
时间窗: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Trigger Hand)
时间窗: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Right)
时间窗: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Non-Trigger Hand)
时间窗: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Both)
时间窗: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
次要结局
- DOEHRSHC Shift(Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).)
- Significant Change in Tinnitus(Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).)
- Total THI Score Change(Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).)
- EWS STS Shift(Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).)