drugset / Trial / NCT00802529
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Phase 2/3
Completed
60 enrolled
Imperial College London
Imperial College Healthcare NHS Trust · collabMedical Research Council · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.
Timeline
- Start
- 2009-04
- Primary completion
- 2015-05
- Completion
- 2015-05
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Steroid (Methylprednisolone) vs Gentamicin; p = 0.271; ANOVA; note: P-value for Drug x Time interaction. NCT00802529 ↗
paper mean difference -0·9, 95% CI -3·4 to 1·6). PMID 27865535 ↗
Publications
- Sjogren J, Fransson PA, Magnusson M, Karlberg M, Tjernstrom F. Acute unilateral vestibulopathy and corticosteroid treatment - A randomized placebo-controlled double-blind trial. J Vestib Res. 2025 Mar;35(2):91-101. doi: 10.1177/09574271241307649. Epub 2024 Dec 18.
- Patel M, Agarwal K, Arshad Q, Hariri M, Rea P, Seemungal BM, Golding JF, Harcourt JP, Bronstein AM. Intratympanic methylprednisolone versus gentamicin in patients with unilateral Meniere's disease: a randomised, double-blind, comparative effectiveness trial. Lancet. 2016 Dec 3;388(10061):2753-2762. doi: 10.1016/S0140-6736(16)31461-1. Epub 2016 Nov 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gentamicin | Small molecule | 40 mg/ml | Other |
| Subject | Methylprednisolone | Other / unclassified | 62.5 mg/ml | Other |