Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic SteroidNCT04129697
Intratympanic Steroids for Sudden Hearing Loss
A study testing Dexamethasone or Methylprednisolone in people with Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
For patients with sudden hearing loss, the initial treatment is not usually effective. We use Dexamethasone or Methylprednisolone to be an Intratympanic steroid administration as a salvage treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid
- What is being tested?
- Dexamethasone or Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sudden hearing loss and initial treatment is not effective
Who cannot join
- the patients refused intratympanic steroids treatment.
About this study
Official title: Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study
For patients with sudden hearing loss, the initial treatment is not usually effective. We use Dexamethasone or Methylprednisolone to be an Intratympanic steroid administration as a salvage treatment. An randomized, double-blind, multi-center study is designed to find the difference between Dexamethasone or Methylprednisolone.
- Being tested
- Dexamethasone or Methylprednisolone
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone or MethylprednisoloneDrug
steroids
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone or Methylprednisolone |
| Methylprednisolone | Active comparator | Not described Receives: Drug: Dexamethasone or Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing
the hearing level after treatment
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic SteroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129697
- Sponsor's protocol ID
- 2019SHLRCT
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of the study could be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study
- ClinicalTrials.gov ID
- NCT04129697
- Acronym / sponsor ID
- 2019SHLRCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For patients with sudden hearing loss, the initial treatment is not usually effective. We use Dexamethasone or Methylprednisolone to be an Intratympanic steroid administration as a salvage treatment. An randomized, double-blind, multi-center study is designed to find the difference between Dexamethasone or Methylprednisolone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasone or Methylprednisolone |
| Methylprednisolone | Active comparator | Drug: Dexamethasone or Methylprednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sudden hearing loss and initial treatment is not effective
Key exclusion criteria (1 listed)
- the patients refused intratympanic steroids treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone or Methylprednisolonesteroids | Drug | Dexamethasone, Methylprednisolone |
Primary outcome
hearing
Time frame: six month
the hearing level after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Individual participant dataSharing planned: Undecided. The results of the study could be shared with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone or Methylprednisolone in people with Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.