E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate accidental evidence (casuistic findings) in more detail and to show efficacy of vardenafil superior over placebo in the treatment of chronic tinnitus |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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 < 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
• total score of the Tinnitus Questionnaire |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
clean database = end of trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |