Evaluation of vardenafil for the treatment of subjective tinnitus: A controlled pilot study
- Conditions
- chronic tinnitus
- Registration Number
- EUCTR2006-000463-29-DE
- Lead Sponsor
- Bayer Healthcare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
•Male and female patients, age 18-64 years
•Chronic subjective cochlear tinnitus
•No treatment of tinnitus within 4 weeks prior to study entry
•Duration of tinnitus > 3 months
•Documented, signed and dated written Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
At Screening
A) Previous or Current Medical Conditions
•Acute tinnitus
•Intermittent tinnitus
•History of M. Menieré
•History of conductive deafness
•History of psychogenic deafness
•History of tumors of the middle ear, inner ear or cerebello-pontine angle
(malignant and non malignant)
•Patients diagnosed of multiple sclerosis
•Any unstable medical, psychiatric, or substance abuse disorder that,
in the opinion of the investigator, is likely to affect the subject's ability to
complete the study or precludes the subject’s participation in the study
•Hereditary degenerative retinal disorders such as retinitis pigmentosa
•History of NAION
•History of positive test for Hepatitis B surface antigen (HbsAg)
or Hepatitis C
•Severe chronic or acute liver disease, including history of moderate
(Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
•Clinically significant chronic hematological disease which may lead to
priapism such as sickle cell anemia, multiple myeloma or leukemia
•Clinically significant bleeding disorder
•Significant active peptic ulceration
•Any underlying cardiovascular condition including unstable angina pectoris
that would preclude sexual activity
•History of myocardial infarction, stroke, or life-threatening arrhythmia
within the prior 6 months
•Uncontrolled atrial fibrillation/flutter at screening (ventricular response
rate > 100 bpm)
•Resting hypotension (a resting systolic blood pressure of < 90 mm Hg)
or hypertension (a resting systolic blood pressure > 170 mm Hg
or a resting diastolic blood pressure >110 mm Hg)
•Symptomatic postural hypotension within 6 months of Visit 1
•History of malignancy within the past 5 years (other than squamous
or basal cell skin cancer)
•Life expectancy < 3 years
B) Concomitant Medication
•Nitrates or nitric oxide donors (including nicorandil)
•Any other concurrent treatment of tinnitus during study
•Previous use of vardenafil or any other PDE5 inhibitor
•Anti-coagulants, with the exception of anti-platelet agents
•Any of the following potent inhibitors of cytochrome P- 450 3A4:
- HIV protease inhibitors such as ritonavir or indinavir;
- anti-mycotic agents itraconazole and ketoconazole
(topical forms are allowed);
- erythromycin
•Any investigational drug (including placebo) within 4 weeks
of Visit 1
•alpha1 adrenoceptor antagonists (alpha blockers) during entire course
of the study
D) Other Exclusions
•women of childbearing age without adequate contraceptive protection
(no hormonal contraception allowed)
•pregnancy and period of breast feeding
•Known hypersensitivity to vardenafil, Bay 38-9456 (also known as
SB-782528) or any component of the investigational medication
•Illiterate or unable to understand questionnaires
•Unwilling or unable to complete questionnaires
• subjects committed to an institution due to an official or judicial directive
At Randomization
A) Abnormal Laboratory Values
•Creatinine clearance < 30 ml/min
(according to formula by Cockroft and Gault)
•Elevation of AST and/or ALT >= 3 x the ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate accidental evidence (casuistic findings) in more detail and to show efficacy of vardenafil superior over placebo in the treatment of chronic tinnitus;Secondary Objective: none;Primary end point(s): •total score of the Tinnitus Questionnaire
- Secondary Outcome Measures
Name Time Method