Trial · NCT04768569
Noise-Induced Hearing Loss-Acute Exposure Treatment
NCT04768569, Phase 2, Terminated, Washington University School of Medicine; results first posted 2025-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Noise-Induced Hearing Loss-Acute Exposure Treatment. Trials, record NCT04768569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04768569
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Noise-Induced Hearing Loss-Acute Exposure Treatment
- NCT number
- NCT04768569
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Hearing Loss, Noise-Induced
- Interventions
- Zonisamide 100Mg Cap, Placebo
- First posted
- 2021-02-24
- Last updated
- 2025-01-15
- Results first posted
- 2025-01-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Ratio of PTS-positive Subjects | 30 days | The primary efficacy endpoint will be the proportion of PTS-positive subjects defined as the ratio of PTS-positive subjects to total number of subjects within each study arm/group. Subjects defined as PTS-positive will demonstrate an increase in threshold that is ≥10 dB HL at any frequency from 2-6 kHz post-surgery as compared to baseline audiogram. |
| Secondary | The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift | 30 days | The secondary efficacy outcome measures will be the rate of temporary cochlear change as measured by a DPOAE amplitude shift at any frequency that is significantly greater than the stability of each measurement (i.e., 95% confidence interval of each measurement do not overlap). The rate of DPOAE shift is the ratio of DPOAE shift-positive subjects to total subjects within each arm. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Ratio of PTS-positive Subjects | 30 days | ITT Sample Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift | 30 days | ITT Sample | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Ratio of PTS-positive Subjects | Zonisamide Pre-op + Placebo Post-op | PTS-positive Subjects at Post-op 30 Days Visit | 3 | Participants | |
| The Ratio of PTS-positive Subjects | Placebo Pre-op + Placebo Post-op | PTS-positive Subjects at Post-op 30 Days Visit | 1 | Participants | |
| The Ratio of PTS-positive Subjects | Placebo Pre-op + Zonisamide Post-op | PTS-positive Subjects at Post-op 30 Days Visit | 1 | Participants | |
| The Ratio of PTS-positive Subjects | Zonisamide Pre-op + Placebo Post-op | PTS-negative Subjects at Post-op 30 Days Visit | 5 | Participants | |
| The Ratio of PTS-positive Subjects | Placebo Pre-op + Placebo Post-op | PTS-negative Subjects at Post-op 30 Days Visit | 6 | Participants | |
| The Ratio of PTS-positive Subjects | Placebo Pre-op + Zonisamide Post-op | PTS-negative Subjects at Post-op 30 Days Visit | 7 | Participants | |
| The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift | Zonisamide Pre-op + Placebo Post-op | No shift | 2 | Participants | |
| The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift | Placebo Pre-op + Placebo Post-op | No shift | 2 | Participants | |
| The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift | Placebo Pre-op + Zonisamide Post-op | No shift | 1 | Participants | |
| The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift | Zonisamide Pre-op + Placebo Post-op | Shift | 4 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zonisamide Pre-op + Placebo Post-op | 8 | |
| Overall Study | STARTED | Placebo Pre-op + Placebo Post-op | 7 | |
| Overall Study | STARTED | Placebo Pre-op + Zonisamide Post-op | 8 | |
| Overall Study | COMPLETED | Zonisamide Pre-op + Placebo Post-op | 8 | |
| Overall Study | COMPLETED | Placebo Pre-op + Placebo Post-op | 7 | |
| Overall Study | COMPLETED | Placebo Pre-op + Zonisamide Post-op | 8 | |
| Overall Study | NOT COMPLETED | Zonisamide Pre-op + Placebo Post-op | 0 | |
| Overall Study | NOT COMPLETED | Placebo Pre-op + Placebo Post-op | 0 | |
| Overall Study | NOT COMPLETED | Placebo Pre-op + Zonisamide Post-op | 0 |
Source ClinicalTrials.gov
Adverse events129
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 | Leukocytosis | Blood and lymphatic system disorders | Zonisamide Pre-op + Placebo Post-op | 1 | 8 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo Pre-op + Placebo Post-op | 1 | 7 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo Pre-op + Zonisamide Post-op | 1 | 8 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Zonisamide Pre-op + Placebo Post-op | 1 | 8 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Placebo Pre-op + Placebo Post-op | 0 | 7 | 0 |
| other | Dysphagia | Gastrointestinal disorders | Placebo Pre-op + Zonisamide Post-op | 0 | 8 | 0 |
| other | Pain | General disorders | Zonisamide Pre-op + Placebo Post-op | 1 | 8 | 1 |
| other | Pain | General disorders | Placebo Pre-op + Placebo Post-op | 0 | 7 | 0 |
| other | Pain | General disorders | Placebo Pre-op + Zonisamide Post-op | 0 | 8 | 0 |
| other | Urinary Tract Infection | Infections and infestations | Zonisamide Pre-op + Placebo Post-op | 1 | 8 | 1 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zonisamide Pre-op + Placebo Post-op | 0 | 8 |
| Total, all-cause mortality | Placebo Pre-op + Placebo Post-op | 0 | 7 |
| Total, all-cause mortality | Placebo Pre-op + Zonisamide Post-op | 0 | 8 |
| Total, other adverse events | Zonisamide Pre-op + Placebo Post-op | 8 | 8 |
| Total, other adverse events | Placebo Pre-op + Placebo Post-op | 7 | 7 |
| Total, other adverse events | Placebo Pre-op + Zonisamide Post-op | 8 | 8 |
| Total, serious adverse events | Zonisamide Pre-op + Placebo Post-op | 2 | 8 |
| Total, serious adverse events | Placebo Pre-op + Placebo Post-op | 1 | 7 |
| Total, serious adverse events | Placebo Pre-op + Zonisamide Post-op | 1 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT04768569
GET https://conductscience.org/api/trials/v1/NCT04768569/events?page=2