High Dose Oral Steroids in Sudden Sensorineural Hearing Loss

NCT03255473 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 16-2342
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing loss).

Conditions

Sudden Sensorineural Hearing Loss (SSNHL)

Outcome Measures

Primary Outcomes (1)

• Changes in Hearing Threshold (Hearing Improvement)

  Pure tone averages (from pure tone audiometry) will be recorded for participants at each visit, and assessed for changes in pure tone average over time. Based on a change in pure tone average, participants will be categorized into the different groups.

  Baseline, 1 week, 1 month, 3 months

Secondary Outcomes (4)

• Changes in Word Recognition Scores

  1 week, 1 month, 3 months, and assessed for change from baseline score.

• Changes in Pure Tone Averages

  1 week, 1 month, 3 months, and assessed for change from baseline pure tone average..

• Clinical Frequency Analysis Based on Hearing Improvement

  Baseline, 1 week, 1 month, 3 months

• Clinical Percentage Analysis Based on Hearing Improvement

  Baseline, 1 week, 1 month, 3 months

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

All subject identification (ID) numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.

Drug: Dexamethasone

Prednisone

ACTIVE COMPARATOR

All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.

Drug: Prednisone

Interventions

Dexamethasone DRUG

All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.

Also known as: dexamethasone sodium phosphate

Dexamethasone

Prednisone DRUG

All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.

Also known as: Deltasone

Prednisone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 80 years old
• Present to the Otology or Otolaryngology Clinic at the University of Colorado Hospital with unilateral sudden sensorineural hearing loss (SSNHL)
• Seen within six weeks of initial hearing loss
• Unilateral hearing loss at screening as defined by:
• Loss of 30 decibels (dB) HL or greater over 3 continuous frequencies with participants reporting that this hearing loss occurred within 3 days
• Present with primary complaint of sensorineural hearing loss
• Normal tympanometry (Type A)
• Normal tympanic membrane

You may not qualify if:

• Participants for whom high dose corticosteroids are a contraindicated due to:
• Pregnancy
• Known allergies to corticosteroids
• Other concurrent medical conditions and or medications where high dose oral corticosteroids are not safe to use
• Participants who have Type 1 or Type 2 diabetes
• Participants who have previously received a course of oral steroids for this indication
• Participants who have bilateral SSNHL
• Participants with conductive hearing loss, mixed hearing loss (sensorineural and conductive), or any type of hearing loss that is not SSNHL (i.e. caused by acoustic or physical trauma to the ear)
• Participants with the following conditions/situations will be excluded because the possibility that these could cause SSNHL:
• History of previous/recurrent unilateral SSNHL
• History of fluctuating hearing in either ear
• History of Meniere's syndrome
• History of chronic granulomatous or suppurative otitis media or cholesteatoma in either ear
• History of otosclerosis in either ear
• Participants with the following conditions/situations will be excluded due to risk of misclassification of diagnosis of idiopathic SSNHL or because these participants are at higher risk for potential steroid side effects due to other comorbidities. If the time line is not otherwise stated, then the participant will be excluded if they experienced these criteria at any point in their lifetime:

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Dexamethasone; dexamethasone 21-phosphate; Prednisone

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienediols

Study Officials

• Stephen P Cass, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL within six weeks, and compare side effect profiles between the two treatment regimens of either dexamethasone or prednisone.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 21, 2017
• Study Start: August 30, 2017
• Primary Completion: August 1, 2022
• Study Completion: March 13, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)