Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335920
Status:
COMPLETED
Last Update Posted:
2008-02-05
First Post:
2006-06-09
Brief Title:
Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With Sudden Hearing Loss
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Inner ear topical dexamethason | None | None | None |