At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
Methylprednisolone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial
In Brief
A Phase 3 clinical trial evaluating Methylprednisolone and Gentamicin for Meniere's Disease. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeniere's Disease
CountriesUnited Kingdom
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartApr 2009
Primary CompletionMay 2015
TodayJul 2026
First PostedDec 5, 2008
Enrollment StartApr 1, 2009
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 17.6 years ago
Interventions
Methylprednisolonedrug
2 transtympanic injections at interval of two weeks.
Gentamicindrug
2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.