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NCT02903355 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)
A Phase 3 study, sponsored by Southern Illinois University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 351
- Enrollment target
NCT02903355: Clinical Trial Phase 3 study, sponsored by Southern Illinois University.
NCT02903355 is a Phase 3 study that was terminated before completion, run by Southern Illinois University. The registered enrollment target is 351 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02903355, a Phase 3 study, was terminated before completion, sponsored by Southern Illinois University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 351 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG D-methionine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-12 |
| Phase | Phase 3 |
Why NCT02903355 stopped before completion
NCT02903355 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02903355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02903355 about?
NCT02903355 is a clinical study titled "Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)". 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 noi...
What is the current status of trial NCT02903355?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2013-09. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02903355?
The interventions under investigation include: Placebo (DRUG), D-methionine (DRUG).
Who is sponsoring clinical trial NCT02903355?
This trial is sponsored by Southern Illinois University, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02903355's enrollment target sits among peer trials
351 1033rd of 2000 higher than 967 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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