Sildenafil For Meniere's Disease - Full Text View

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Dizziness and Vertigo Meniere's Disease Nausea and Vomiting Tinnitus Toe Injuries and Disorders

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

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

Additional 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

No publications provided

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

Additional relevant MeSH terms:

Vasodilator Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Meniere Disease
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents

Ear Diseases
Pharmacologic Actions
Phosphodiesterase Inhibitors
Endolymphatic Hydrops
Therapeutic Uses
Labyrinth Diseases

ClinicalTrials.gov processed this record on November 09, 2009