Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meniere's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Meniere's DiseaseSildenafil For Meniere's Disease
NCT00145483
- Bondi Junction, New South Wales
- Brisbane, Queensland
- East Melbourne, Victoria
- Melbourne, Victoria
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| 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 | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Meniere's Disease | |||
| Intervention ICMJE | Drug: Sildenafil | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 163 | |||
| Original Enrollment ICMJE | 180 | |||
| Actual Study Completion Date ICMJE | November 8, 2006 | |||
| Actual Primary Completion Date | November 8, 2006 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Australia | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00145483 | |||
| Other Study ID Numbers ICMJE | A1481107 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||