chronic tinnitus
Conditions
Interventions
Trade Name: Levitra 10 mg Filmtabletten
Product Name: Levitra 10 mg Filmtabletten
Product Code: Bay 38-9456 / SB-782528
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vardenafil
Current
Sponsors
Bayer Healthcare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: 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 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 x the ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed