Sildenafil For Meniere's Disease

Meniere's Disease Clinical Trial

Official title:

A Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study Of The Efficacy and Safety Of Sildenafil Given For The Acute Treatment Of Meniere's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145483
• Other study ID #: A1481107
• Status: Completed
• Phase: Phase 4
• Start date: June 18, 2002
• Est. completion date: November 8, 2006

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: November 8, 2006
• Est. primary completion date: November 8, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• Sildenafil

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Bondi Junction	New South Wales
Australia	Pfizer Investigational Site	Brisbane	Queensland
Australia	Pfizer Investigational Site	East Melbourne	Victoria
Australia	Pfizer Investigational Site	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Secondary	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

External Links

•   To obtain contact information for a study center near you, click here.