Sudden DeafnessPhase 3NCT00335920
Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With Sudden Hearing Loss
A Phase 3 study testing Dexamethasone-dihydrogenphosphate (4mg/ml) in people with Sudden Deafness, run by University Hospital Tuebingen at 3 sites in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of an intratympanic continuous two-week application of dexamethasone compared to placebo using a temporarily implanted catheter in patients with severe to profound sudden sensorineural hearing loss and insufficient recovery after initial systemic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sudden Deafness
- What is being tested?
- Dexamethasone-dihydrogenphosphate (4mg/ml)
- How many people
- 23 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2003to Jul 2007
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Age is greater than 18 years old and less than 75 years old.
- Diagnosis of unilateral Idiopathic sudden sensorineural hearing loss (i.e. sudden sensorineural hearing loss of unknown etiology
- Sensorineural hearing loss is at least 50 dB or more for three or more frequencies in standard pure tone, bone-conducted audiogram within the range of 500 Hz to 4000 Hz (500, 1000, 2000, 3000 and 4000), 60 dB or more for two of these frequencies or 70 dB or more for any frequency within this range, or a decrease in the SRT to 70 dB or greater (not accounted for by conductive hearing loss) or a drop in speech discrimination score to less than or equal to 30%
- hearing loss occurred within 72 hours
- Hearing loss occurred at least 12 days ago but less than or equal to 21 days ago
- Insufficient recovery of the ISSNHL at least 12 days after onset whether or not the patient received Local Standard Therapy (i.e. Hearing in the contralateral ear is at least 20 dB better than the affected ear in at least three frequencies (any three of 500, 1000, 2000, 3000, 4000 Hz))
Who cannot join
- Age is less than 18 or greater than 75 years old
- Hearing loss occurred less than 12 days or more than 21 days ago
- Positive pregnancy test, risk of pregnancy (insufficient protection or lactation
- Middle ear inflammation or effusion
- Ear canal inflammation
- Conductive hearing loss of greater than 10 dB
Show all 21Show fewer
- Sudden bilateral hearing loss
- Presence of any conditions or symptoms which indicate that the hearing loss is not ISSNHL, for example, acoustic trauma, Meniere's disease, fluctuating hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion, hearing loss due to ear surgery, perilymph fistula or barotrauma.
- Pulse synchronic tinnitus (potentially due to glomus jugulare tumor)
- Previous otologic surgery (excluding ventilation tubes)
- History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc.
- Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
- Use of non-permitted treatment during the study
- Intake of experimental drugs or participation in a clinical study within the last 30 days
- Only hearing ear
- History of drug abuse or alcoholism
- History of an ischemic disorder (previous strokes, previous heart attacks, peripheral arterial occlusion disease)
- Patient is not capable of understanding the informed consent form (whether due to its language or for other reasons)
- Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants, hypnotics or anxiolytics which has/have been prescribed within three month preceding inclusion into the study and/or cannot be continued at the same dose during the study
- Any severe (systemic) neurological disease (e.g. Epilepsy, Parkinson's disease, Dementia/Alzheimer's disease, Multiple sclerosis)
- Any reason, in the investigator's opinion, that prohibits inclusion into the study
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
St. Vincentius Kliniken, Klinik für HNO Heilkunde
Karlsruhe, 76042
Department of Otorhinolaryngology, University of Tubingen
Tübingen, 72076
Bundeswehrkrankenhaus Ulm
Ulm, 89081
About this study
Official title: A Prospective, Randomized, Double Blind, Placebo Controlled, Multicenter Study on the Safety and Efficacy of Continuous Infusion of Corticosteroid Delivered Via Catheter in Patients With Idiopathic Sudden Sensorineural Hearing Loss
The purpose of this study is to evaluate the efficacy and safety of an intratympanic continuous two-week application of dexamethasone compared to placebo using a temporarily implanted catheter in patients with severe to profound sudden sensorineural hearing loss and insufficient recovery after initial systemic prednisolone therapy.
Read the detailed description
Patients suffering from unilateral severe to profound sudden sensorineural hearing loss (ISSNHL) or anacusis with no or insufficient recovery after 12-21 days after onset will be treated for 14 days with Dexamethasone or placebo delivered intratympanically via a micro-catheter temporarily implanted into the round window niche and an external mini-pump.
Due to the relatively unknown risks of intratympanic treatment by catheter implantation, a significant spontaneous recovery rate and an existing standard therapy for ISSNHL in Germany (systemic glucocorticoids), patients will only be enrolled into the study if no or insufficient recovery of hearing threshold could be observed after initial systemic therapy.
The study will be carried out until 10 patients per group have been randomized regardless in which study center they have been randomized. After the last patient of these 10 patients per group has reached the endpoint an interim analysis will be done. The statistical estimation of the total number of subjects to be randomized will be completed after this interim analysis by the responsible statistician.
- Conditions
- Sudden Deafness
- Being tested
- Dexamethasone-dihydrogenphosphate (4mg/ml)
- Keywords
- Sudden Hearing Loss, intratympanic, steroids
- 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-dihydrogenphosphate (4mg/ml)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure tone audiometric threshold
Secondary outcomes (3)
Word recognition (speech audiometry)
tinnitus improvement
adverse events (worsening of hearing and/or vertigo and/or tinnitus, middle ear inflammation, pain)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startOct 2003
- Primary completionJul 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sudden DeafnessStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Peter Zenner, M.D., Principal investigator, Department of Otorhinolaryngology, University of TubingenStefan K Plontke, M.D., Study director, Department of Otorhinolaryngology, University of Tubingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335920
- Sponsor's protocol ID
- LOCAL DEX-ISSNHL
- Other IDs
- Inner ear topical dexamethason
- Status last verified
- Feb 2008
- First submitted
- 9 Jun 2006
- Last updated
- 5 Feb 2008
- Results posted
- No
Publications
Plontke SK, Lowenheim H, Mertens J, Engel C, Meisner C, Weidner A, Zimmermann R, Preyer S, Koitschev A, Zenner HP. Randomized, double blind, placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via a round window catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy. Laryngoscope. 2009 Feb;119(2):359-69. doi: 10.1002/lary.20074.
PubMed 19172627
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind, Placebo Controlled, Multicenter Study on the Safety and Efficacy of Continuous Infusion of Corticosteroid Delivered Via Catheter in Patients With Idiopathic Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT00335920
- Acronym / sponsor ID
- LOCAL DEX-ISSNHL
- Conditions
- Sudden Deafness
- Keywords
- Sudden Hearing Loss, intratympanic, steroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Jun 2006 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy and safety of an intratympanic continuous two-week application of dexamethasone compared to placebo using a temporarily implanted catheter in patients with severe to profound sudden sensorineural hearing loss and insufficient recovery after initial systemic prednisolone therapy.
Detailed description
Patients suffering from unilateral severe to profound sudden sensorineural hearing loss (ISSNHL) or anacusis with no or insufficient recovery after 12-21 days after onset will be treated for 14 days with Dexamethasone or placebo delivered intratympanically via a micro-catheter temporarily implanted into the round window niche and an external mini-pump.
Due to the relatively unknown risks of intratympanic treatment by catheter implantation, a significant spontaneous recovery rate and an existing standard therapy for ISSNHL in Germany (systemic glucocorticoids), patients will only be enrolled into the study if no or insufficient recovery of hearing threshold could be observed after initial systemic therapy.
The study will be carried out until 10 patients per group have been randomized regardless in which study center they have been randomized. After the last patient of these 10 patients per group has reached the endpoint an interim analysis will be done. The statistical estimation of the total number of subjects to be randomized will be completed after this interim analysis by the responsible statistician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent form
- Age is greater than 18 years old and less than 75 years old.
- Diagnosis of unilateral Idiopathic sudden sensorineural hearing loss (i.e. sudden sensorineural hearing loss of unknown etiology
- Sensorineural hearing loss is at least 50 dB or more for three or more frequencies in standard pure tone, bone-conducted audiogram within the range of 500 Hz to 4000 Hz (500, 1000, 2000, 3000 and 4000), 60 dB or more for two of these frequencies or 70 dB or more for any frequency within this range, or a decrease in the SRT to 70 dB or greater (not accounted for by conductive hearing loss) or a drop in speech discrimination score to less than or equal to 30%
- hearing loss occurred within 72 hours
Key exclusion criteria (21 listed)
- Age is less than 18 or greater than 75 years old
- Hearing loss occurred less than 12 days or more than 21 days ago
- Positive pregnancy test, risk of pregnancy (insufficient protection or lactation
- Middle ear inflammation or effusion
- Ear canal inflammation
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-dihydrogenphosphate (4mg/ml) | Drug | – |
Primary outcome
Pure tone audiometric threshold
3 secondary outcomes
Word recognition (speech audiometry)
tinnitus improvement
adverse events (worsening of hearing and/or vertigo and/or tinnitus, middle ear inflammation, pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2008.
- Derived from this study: PubMed 19172627Plontke SK, Lowenheim H, Mertens J, Engel C, Meisner C, Weidner A, Zimmermann R, Preyer S, Koitschev A, Zenner HP. Randomized, double blind, placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via a round window catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy. Laryngoscope. 2009 Feb;119(2):359-69. doi: 10.1002/lary.20074.
Related trials for Sudden Deafness
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
Not yet recruitingPhase 3
Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL)
Not yet recruitingPhase 2
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingPhase 4
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss
Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
Sudden Sensorineural Hearing Loss (SSNHL), Prediabetes / Type 2 Diabetes
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.
Hans-Peter Zenner, M.D. principal investigator
Department of Otorhinolaryngology, University of Tubingen
Stefan K Plontke, M.D. study director
Department of Otorhinolaryngology, University of Tubingen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone-dihydrogenphosphate (4mg/ml) in people with Sudden Deafness, run by University Hospital Tuebingen at 3 sites in Germany.
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 7 inclusion and 21 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: finished, as of the sponsor's last update on 5 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pure tone audiometric threshold. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335920, which also lists 1 linked publication.
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 5 Feb 2008.