Overview

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

Status:
Terminated
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Southern Illinois University
Treatments:
Sorbitol
Criteria
Inclusion criteria:

Male or female 21 to 45 years of age Negative pregnancy test at enrollment and prior to
taking study drug Willing to use an effective method of birth control during the study
(Both male and female participants should avoid pregnancy during study) Pure tone air
conduction threshold average at 0.5, 1 and 2 kHz of no greater than 40 dB HL bilaterally
with no air bone gaps greater than 10 dB and normal otoscopy and tympanometry screens
Willing to refrain from using supplements containing or derived from protein while
participating in this study Ability to comply with all study requirements

Exclusion criteria:

History of allergic or idiosyncratic reaction to methionine, amino acid mixtures,
nutritional supplements, egg white, or other proteins or food additives Vegetarian
(Individual excludes meat and fish from their diet) History of chronic balance disorders
Abnormal otoscopic findings, otologic surgery, autoimmune inner ear disease, significant
air-bone gaps, abnormal tympanograms or other indication of middle-ear abnormality, history
of fluctuant hearing or asymmetric hearing worse than 25 dB at any frequency in either ear,
perilymphatic fistula, tumor of the auditory system, or other CNS disorder that is likely
to affect hearing Treatment with intravenous (IV) antibiotics within the past 6 months Any
surgical or medical condition which might significantly alter the absorption, distribution,
metabolism, or excretion of any drug Treatment for alcohol or substance abuse within past 6
months Women of childbearing age who are not using effective contraceptive methods and who
may become pregnant during the course of the study Women who are pregnant or breastfeeding.
National Guardsmen History of psychotic schizophrenia Exposure within the previous 6 months
to systemic ototoxic substances including aminoglycosides or vancomycin Body weight
exceeding 225 pounds Renal impairment measured as eGFR < 50 on screening creatinine
clearance blood draw.