Sildenafil For Meniere's Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

January 30, 2008

Start Date ^ICMJE

June 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

1. Vertigo Response (4 x 6 point scale)
Primary Endpoints
2. Balance (6 point scale)

Change History

Complete list of historical versions of study NCT00145483 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Secondary Efficacy Variables: 1. Hearing/Tinnitus (6 point scale)
2. Ear, Nose and Pressure/Fullness (6 point scale)
3. Performing daily activities (6 point scale)
4. Nausea (Y/N)
5. Vomiting (Y/N)
6. Functional Response (4 point scale)
7. Duration of the

Descriptive Information

Brief Title ^ICMJE

Sildenafil For Meniere's Disease

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Meniere's Disease

Intervention ^ICMJE

Drug: Sildenafil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00145483

Responsible Party

Study ID Numbers ^ICMJE

A1481107

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP