Trial · NCT00097448

Sudden Deafness Treatment Trial

NCT00097448, Phase 3, Completed, Massachusetts Eye and Ear Infirmary; results first posted 2013-04-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sudden Deafness Treatment Trial. Trials, record NCT00097448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00097448

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sudden Deafness Treatment Trial
NCT number: NCT00097448
Status: Completed
Phases: Phase 3
Enrollment: 255 participants, actual
Lead sponsor: Massachusetts Eye and Ear Infirmary
Conditions: Sudden Deafness
Interventions: prednisone, methylprednisolone sodium succinate
First posted: 2004-11-24
Last updated: 2017-04-04
Results first posted: 2013-04-04

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hearing Improvement	2 months	Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hearing Improvement	2 months	Intention-to-treat	dB	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Hearing Improvement	Oral Steroids		30.7	Standard Deviation 21.7	dB
Hearing Improvement	IT Steroids		28.7	Standard Deviation 21.5	dB

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oral Steroids	125
Overall Study	STARTED	Intratympanic Steroids	130
Overall Study	COMPLETED	Oral Steroids	121
Overall Study	COMPLETED	Intratympanic Steroids	129
Overall Study	NOT COMPLETED	Oral Steroids	4
Overall Study	NOT COMPLETED	Intratympanic Steroids	1

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Ear pain	Ear and labyrinth disorders	Oral Steroids	4	125	4
other	Ear pain	Ear and labyrinth disorders	IT Steroids	70	130	186
other	Vertigo	Ear and labyrinth disorders	Oral Steroids	13	125	14
other	Vertigo	Ear and labyrinth disorders	IT Steroids	35	130	49
other	Hyperglycemia	Endocrine disorders	Oral Steroids	36	125	39
other	Hyperglycemia	Endocrine disorders	IT Steroids	21	130	21
other	Eaer infection	Ear and labyrinth disorders	Oral Steroids	2	125	2
other	Eaer infection	Ear and labyrinth disorders	IT Steroids	7	130	7
other	Sleep disturbance	Nervous system disorders	Oral Steroids	44	125	44
other	Sleep disturbance	Nervous system disorders	IT Steroids	9	130	9

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral Steroids
Total, all-cause mortality	IT Steroids
Total, other adverse events	Oral Steroids	121	125
Total, other adverse events	IT Steroids	127	130
Total, serious adverse events	Oral Steroids	5	125
Total, serious adverse events	IT Steroids	6	130

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21610239	DERIVED	PubMed
22805100	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DC006296	Sudden Hearing Loss Multicenter Treatment Trial	RAUCH, STEVEN D.	MASSACHUSETTS EYE AND EAR INFIRMARY	NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS	2004 to 2008

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Oral Steroids vs IT Steroids: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00097448

GET https://conductscience.org/api/trials/v1/NCT00097448/events?page=2

API reference For AI assistants