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Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)

NCT02903355 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2022-06-28

Study results available
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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.

Conditions

  • Noise-induced Hearing Loss

Interventions

DRUG

D-methionine

D-methionine, oral liquid suspension

DRUG

Placebo

Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.

Sponsors & Collaborators

  • Southern Illinois University

    lead OTHER

Principal Investigators

  • Kathleen Campbell, PhD · MetArmor, Inc.

  • CPT William Grimes, MD · United States Department of Defense, US Army Ft. Jackson, South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903355 on ClinicalTrials.gov