deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT00802529

Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial

Sponsor: Imperial College Healthcare NHS Trust

Updated 7 times since 2017 Last updated: Jun 19, 2019 Started: Apr 30, 2009 Primary completion: May 31, 2015 Completion: May 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00802529, this PHASE2/PHASE3 trial focuses on Meniere's Disease and remains completed. Sponsored by Imperial College Healthcare NHS Trust, it has been updated 7 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. In one out of five patients, standard first line medical treatment is not effective in controlling vertigo attacks. For these incapacitated patients, gentamicin injections through the ear drum is a well established minimally invasive treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. As hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. On the other hand, steroids are drug of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without any known side effects during local treatment in ear. We will compare the two in this randomised, double blind trial.

Meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. In one out of five patients, standard first line medical treatment is not effective in controlling vertigo attacks. For these incapacitated patients, gentamicin injections through the ear drum is a well established minimally invasive treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. As hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. On the other hand, steroids are drug of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without any known side effects during local treatment in ear. We will compare the two in this randomised, double blind trial.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jul 2019 · 13 months · monthly snapshotCompleted~Jul 2019 – ~Jan 2021 · 18 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Sep 2024 — Present [monthly]

    Completed PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  5. Jul 2019 — Jan 2021 [monthly]

    Completed PHASE2_PHASE3

Show 2 earlier versions
  1. Jun 2018 — Jul 2019 [monthly]

    Completed PHASE2_PHASE3

  2. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2_PHASE3

    First recorded

Apr 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Imperial College Healthcare NHS Trust
  • Imperial College London
  • Medical Research Council
Data source: Imperial College London

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations