EUCTR2016-000315-32-PL进行中（未招募）1 期
Clinical Trial to Explore Treatment Effects of Ginkgo biloba Extract EGb 761® in Patients with Chronic Tinnitus and Effect Modification by Etiology, Biological Factors and Concomitant Pathologies.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
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
- •1. Outpatient male or female patient at least 18 years old.
- •2. Chronic tinnitus
- •a. may be unilateral or bilateral, with or without concomitant hearing loss;
- •b. grade according to Biesinger* is 2 or 3;
- •c. duration of at least 3 months.
- •3. Written informed consent to participate in the clinical trial, to trial-related treatment and to data recording in accordance with applicable laws.
- •*) Grade 2: The tinnitus is mainly perceived in silence and is disturbing under stress and strain.
- •Grade 3: The tinnitus causes permanent impairment in personal and occupational spheres. Emotional, cognitive and somatic disorders are present.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Participation in another experimental drug trial at the same time or within the past 4 weeks before Baseline Visit.
- •2. Tinnitus due to Ménière's disease, vestibular schwannoma or otosclerosis.
- •3. Any other drug treatments for tinnitus taken currently or within 2 weeks before Baseline Visit.
- •4. Gingko biloba preparation for any reason taken currently or within 4 weeks before Baseline Visit.
- •5. Cognitive behavioral therapy or tinnitus retraining therapy started within 6 months prior to Baseline Visit or planned to be started during the course of the trial.
- •6. Acute or chronic otitis media or acute vestibular neuritis.
- •7. Ongoing psychiatric disorder, such as major depression, generalized anxiety disorder, schizophrenia, etc.
- •Of note: Symptoms of depression or anxiety or other behavioral or psychological symptoms at sub-syndromal level and not requiring treatment with psychotropic drugs are permitted.
- •8. Ongoing severe cardiac or circulatory disorder
- •a. severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris
- •b. decompensated congestive heart failure (NYHA stage IV)
- •c. uncontrolled hypertension with systolic blood pressure above 180 mmHg and / or diastolic blood pressure above 115 mmHg
- •d. clinically significant cardiac arrhythmias (Lown classes IVb and V, bifascicular bundle branch block).
- •9. Severe renal or hepatic dysfunction (defined by serum creatinine or serum ASAT, ALAT or gamma-GT above 3 times the upper limit of the reference range in the anamnesis).
- •10. Ongoing uncontrolled endocrine or hematological disorder.
- •11. Intake of drugs not permitted during participation in the trial, in particular, psychoactive drugs, systemic acting perfusion-enhancing drugs, cognition enhancing drugs, systemic acting anti-cholinergic drugs, regular use of anticoagulants (platelet aggregation inhibitors permitted) during the 2 weeks prior to Baseline Visit.
- •12. Ongoing hemorrhagic diathesis or coagulation disorder.
- •13. Seizure within 2 years prior to Baseline Visit or regular use of anticonvulsive drugs.
- •14. Active malignant disease (exception: prostate cancer which does not require other than hormone treatment within the next 6 months).
- •15. Known hypersensitivity to Ginkgo biloba extract or to excipients contained in the tablets.
- •16. Active peptic ulcer disease or any gastrointestinal disease with potential impairment of the absorption of orally applied drugs (e.g. Billroth I/II, Crohn's disease, ulcerative colitis, any kind of enterectomy).
- •17. Female patients of childbearing potential without safe contraception (any form of hormonal contraception, intrauterine devices, sexual abstinence and partner sterilization are considered sufficiently safe when used consistently and correctly; child-bearing potential can be denied in case of postmenopausal state for at least 2 years, hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
- •18. Planned surgical intervention requiring hospitalization during the clinical trial.
- •19. Previous inclusion in the present clinical trial.
- •20. Incapability of understanding nature, meaning and consequences of the clinical trial.
- •21. Patient unable to read and / or write.
- •22. Patients in custody by juridical or official order.
- •23. Patients, who are members of the staff of the trial center, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator.
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