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

This study is not yet open for participant recruitment.
Verified July 2012 by Southern Illinois University
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Kathleen CM Campbell, PhD, Southern Illinois University
ClinicalTrials.gov Identifier:
NCT01345474
First received: April 27, 2011
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

This prospective study is a randomized, double-blind, placebo-controlled Phase 3 clinical trial of oral 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.


Condition Intervention Phase
Noise-Induced Hearing Loss
 Drug: D-methionine, oral liquid suspension
Other: Placebo Comparator
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3 Clinical Trial: D-Methionine to Reduce Noise-Induced Hearing Loss (NIHL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • Pure tone air conduction threshold [ Time Frame: 22 days after cessation of weapons training ] [ Designated as safety issue: No ]
    Change from baseline in pure-tone thresholds as measured by absolute change and frequency of significant noise-induced threshold shift (STS)


Secondary Outcome Measures:
  • Tinnitus scales [ Time Frame: 22 days after cessation of weapons training ] [ Designated as safety issue: No ]
    Tinnitus questionnaire report of change from baseline in scores for both loudness and annoyance


Estimated Enrollment: 600
Study Start Date: October 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.
 Other: Placebo Comparator
Equal volume placebo.
Experimental: D-methionine, oral liquid suspension
D-methionine liquid suspension also contains sorbitol, orange flavor and purified water
 Drug: D-methionine, oral liquid suspension
Two daily doses of up to 100mg/kg/day of D-met for 18 days
Other Name: D-Met

Detailed Description:

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:

  1. To determine whether administering oral D-met can prevent permanent NIHL after weapons training. This aim will be addressed by comparing the results of D-met versus placebo administration starting 3 days prior to, during the 11 day period of weapons training (Monday-Friday for first week, Monday-Thursday for second week), and 4 days after for a total of 18 days. Pure tone hearing thresholds will be assessed before and 22 days after completion of weapons training (ie; 18 days after the last day of study drug/placebo administration).
  2. To determine whether administering oral D-met can prevent tinnitus after weapons training. This aim will be addressed by comparing the results of D-met versus placebo administration starting 3 days prior to, during the 11 day period of weapons training (Monday-Friday for first week, Monday-Thursday for second week), and 4 days after for a total of 18 days. Tinnitus questionnaires will be assessed before and 22 days after completion of weapons training (ie; 18 days after the last day of study drug/placebo administration).
  3. To monitor for any potential side effects of D-met in human subjects. This aim will be accomplished by subject query on each day study drug is dispensed (twice daily) and at final study visit, routing of any adverse event reports to study medical personnel, statisticians and to the Food and Drug Administration (FDA).
  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Negative pregnancy test confirmed by urine dipstick at enrollment and prior to taking first study drug dose
  • Willing to use an effective method of birth control during the study (Female participants should avoid pregnancy and male participants should avoid fathering children during study). Subject should either abstain from sexual relations or practice a method of birth control while taking part in the study. Except for surgical removal of the uterus, birth control methods such as condoms, a diaphragm or cervical cap, birth control pills, IUD, or sperm killing products are not totally effective in preventing pregnancy. Male study participants should refrain from fathering babies while enrolled in this study.
  • Pure tone air conduction threshold average (PTA) at .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
  • Ability to comply with all study requirements

Exclusion Criteria:

  • History of allergic reaction to methionine, amino acid mixtures, nutritional supplements, egg white, or other proteins or food additives
  • Vegetarian (individual who excludes both meat and fish from their diet)
  • History of 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 asymmetry in hearing worse than 25 dB at any test frequency, or central nervous system disorder that is likely to affect hearing
  • Exposure in the previous 6 months to systemic ototoxic substances including aminoglycoside antibiotics, or chemotherapy with carboplatin, cisplatin, vincristine, vinblastine or difluoromethylornithine
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug
  • Recent history of drug or alcohol abuse
  • 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
  • Army Reservists or National Guardsmen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345474

Contacts
Contact: Kathleen CM Campbell, PhD 217-545-7310 kcampbell@siumed.edu
Contact: Jill Anderson, AuD, PhD 217-545-9700 janderson2@siumed.edu

Locations
United States, South Carolina
US Army Basic Combat Training Center of Excellence Not yet recruiting
Fort Jackson, South Carolina, United States
Contact: LTC Neil Page, MD     803-751-2280     Neil.Page@amedd.army.mil    
Sponsors and Collaborators
Southern Illinois University
Department of Defense
Investigators
Study Director: LTC Neil Page, MD United States Department of Defense, US Army Ft. Jackson, South Carolina
Principal Investigator: Kathleen CM Campbell, CCC-A, PhD Southern Illinois University School of Medicine
  More Information

Additional Information:
NIDCD Fact Sheet on Noise-Induced Hearing Loss  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Kathleen CM Campbell, PhD, Professor and Director, Southern Illinois University
ClinicalTrials.gov Identifier: NCT01345474     History of Changes
Other Study ID Numbers: CAM-SIU-11-002
Study First Received: April 27, 2011
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Southern Illinois University:
noise-induced hearing loss
hearing loss
tinnitus
 weapons training
hearing protection
impulse noise

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural

ClinicalTrials.gov processed this record on May 21, 2013