Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145483
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2005-09-01
Brief Title:
Sildenafil For Menieres Disease
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
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 Menieres Disease
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Menieres disease affects a persons 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 Menieres 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None