Sildenafil For Meniere's Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Meniere's Disease	Drug: Sildenafil	Phase II

MedlinePlus related topics:

Dizziness and Vertigo Meniere's Disease Nausea and Vomiting Tinnitus Toe Injuries and Disorders

Drug Information available for:

Sildenafil citrate Sildenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Vertigo Response (4 x 6 point scale); Balance (6 point scale)

Secondary Outcome Measures:

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

Estimated Enrollment:	180
Study Start Date:	June 2002

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145483

Locations


Australia, New South Wales
	Pfizer Investigational Site
	Bondi Junction, New South Wales, Australia

Australia, Queensland
	Pfizer Investigational Site
	BRISBANE, Queensland, Australia

Australia, Victoria
	Pfizer Investigational Site
	East Melbourne, Victoria, Australia
	Pfizer Investigational Site
	Melbourne, Victoria, Australia

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to CSR.org posting. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A1481107
First Received:	September 1, 2005
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00145483
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Otorhinolaryngologic Diseases

Meniere Disease

Edema

Sildenafil

Ear Diseases

Additional relevant MeSH terms:

Vasodilator Agents

Phosphodiesterase Inhibitors

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Endolymphatic Hydrops

Enzyme Inhibitors

Cardiovascular Agents

Pharmacologic Actions

Labyrinth Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00145483