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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00145483




Registration number
NCT00145483
Ethics application status
Date submitted
1/09/2005
Date registered
5/09/2005
Date last updated
1/02/2021

Titles & IDs
Public title
Sildenafil For Meniere's Disease
Scientific 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
Secondary ID [1] 0 0
A1481107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meniere's Disease 0 0
Condition category
Condition code
Ear 0 0 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/11/2006
Sample size
Target
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Bondi Junction
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Brisbane
Recruitment hospital [3] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Bondi Junction
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00145483
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00145483