Meniere's Disease
Conditions
Brief summary
Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2 hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation of fullness in the affected ear and may be associated with nausea and vomiting. One hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its vasodilatory activity. The purpose of this study is to assess the safety and efficacy of sildenafil (Viagra) compared with placebo on symptoms during one acute attack.
Interventions
DRUGSildenafil
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Active Meniere's disease (2 or more definitive spontaneous episodes of vertigo 20 minutes or longer, plus hearing loss on at least 1 occasion, tinnitus or aural fullness) with confirmed diagnosis
Exclusion criteria
* Pregnant or breast feeding females or fertile females unwilling to use agreed contraceptive methods * severe Meniere's diseased (more than 8 attacks per month) * previous ear surgery * intratympanic perfusions of steroids or gentamicin; requiring other medications contraindicated for Viagra (eg. nitrates) * with medical conditions that make Viagra contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vertigo Response (4 x 6 point scale); Balance (6 point scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Hearing/Tinnitus; Ear, Nose & Pressure/Fullness; Perf. daily activities; Nausea; Vomiting; Func. Response; Duration of the Attack and Vertigo; Rescue Medications Use; Acceptability to subject; Composite Assessment Score; Comparison to Previous Attack | — |
Countries
Australia
Outcome results
None listed