EUCTR2006-000463-29-DE进行中（未招募）不适用
Evaluation of vardenafil for the treatment of subjective tinnitus: A controlled pilot study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •alpha1 adrenoceptor antagonists (alpha blockers) during entire course
- •of the study
- •D) Other Exclusions
- 另有 13 项未显示
研究者
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