Sildenafil For Meniere's Disease

Phase 4

Completed

• Conditions: Meniere's Disease

• Registration Number: NCT00145483
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06-18
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-05
• Primary Completion: 2006-11-08
• Study Completion: 2006-11-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vertigo Response (4 x 6 point scale); Balance (6 point scale)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇺 Melbourne, Victoria, Australia