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Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

This study has been completed.
Sponsor:
Collaborators:
Imperial College Healthcare NHS Trust
Medical Research Council
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00802529
First received: December 4, 2008
Last updated: August 31, 2016
Last verified: February 2016
  Purpose
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.

Condition Intervention Phase
Meniere's Disease
Drug: Methylprednisolone
Drug: Gentamicin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Vertigo Attacks [ Time Frame: 6month pre-enrollment baseline, 18-24 months after initial treatment ] [ Designated as safety issue: No ]
    The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines).


Secondary Outcome Measures:
  • Change in Hearing [ Time Frame: Baseline, 1,2,6,12,18 and 24months after initial treatment ] [ Designated as safety issue: No ]
    Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.

  • Change in Speech Discrimination [ Time Frame: Baseline, 1,2,6,12 and 24months after initial treatment ] [ Designated as safety issue: No ]

    Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.

    Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score.



Enrollment: 60
Study Start Date: April 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Steroid (Methylprednisolone) Drug: Methylprednisolone
2 transtympanic injections at interval of two weeks.
Active Comparator: Gentamicin Drug: Gentamicin
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.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with unilateral Ménière's disease (definite or probable, according to Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. There should be normal, age appropriate hearing in the contralateral ear.

Exclusion Criteria:

  • Patients with Ménière's disease in later stages (not having vertigo attacks).
  • Age: patients older than 70 years at the start of the trial.
  • Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
  • Active additional neuro-otological disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the objective follow up difficult.
  • Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active middle ear disease).
  • Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
  • History of known adverse/allergic reaction to steroids or gentamicin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802529

Locations
United Kingdom
Imperial college Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Medical Research Council
Investigators
Principal Investigator: Adolfo M Bronstein, PhD, FRCP Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00802529     History of Changes
Other Study ID Numbers: CRO1135 
Study First Received: December 4, 2008
Results First Received: May 9, 2016
Last Updated: August 31, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Meniere's disease
transtympanic steroids
Randomised controlled trial

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Gentamicins
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on December 06, 2016