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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 is a Phase 3 study that was terminated before completion, run by Southern Illinois University. The registered enrollment target is 351 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02903355
The ClinicalTrials.gov registry entry for NCT02903355 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Southern Illinois University, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02903355 reports 0 study locations.
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.
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