EUCTR2011-004697-28-CZ进行中（未招募）不适用
Randomised, double-blind trial to compare the treatment effects of Ginkgo biloba extract EGb 761® and pentoxifylline in patients with sub-chronic and chronic tinnitus focussing on psycho-social problems - Tinnitus Czech Republic
Dr. W. Schwabe GmbH & Co. KG0 个研究点开始时间: 2012年3月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Outpatients aged = 40 with unilateral or bilateral, sub-chronic or chronic tinnitus (duration > 3 months)
- •2. Tinnitus is the main complaint, other cochlear or vestibular symptoms may be present but less annoying
- •3. Tinnitus is maskable with noise masking.
- •4. Annoyance rated at least 3 on the 11-Point Box Scale of tinnitus annoyance at screening and baseline.
- •5. Abridged Tinnitus Questionnaire (Mini-TQ) total score rated = 5 at baseline.
- •6. Written informed consent to participate in the clinical trial, to randomized treatment and to data recording in accordance with applicable laws
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment
- •2. Currently taking any treatments for tinnitus
- •3. Acute or chronic otitis media or vestibular neuritis
- •4. Drug-induced tinnitus
- •5. Significant cardiac or circulatory disorder
- •severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris
- •decompensated congestive heart failure (NYHA stage IV)
- •significant coronary sclerosis or history of myocardial infarction
- •uncontrolled hypertension with systolic blood pressure above 180 mmHg and/or diastolic blood pressure above 115 mmHg
- •hypotension with systolic blood pressure below 110 mmHg and/or diastolic blood pressure below 70 mmHg
- •clinically significant cardiac arrhythmias (Lown classes IVb and V, bifascicular bundle branch block)
- •6. Any acute or recent event of bleeding or history of bleeding (in particular intracerebral or retinal bleeding or bleeding from any organ), haemorrhagic diathesis, intake of anticoagulants
- •7. Any surgery within the last 3 months before the start of randomised treatment
- •8. Severe renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or gamma-GT above 3 times the upper limit of the reference range)
- •9. Insulin-dependent or drug-dependent diabetes mellitus
- •10. Systemic lupus erythemathosus (SLE)
- •11. Intake of drugs not permitted during participation in the study, in particular anticoagulants, antidiabetic drugs, insulin, theophylline, cimetidine, psychoactive drugs, other perfusion-enhancing drugs, cognition enhancing drugs or anti-cholinergic drugs (for details see section 6 of protocol)
- •12. Active malignant disease (exception: prostate cancer which does not require other than hormone treatment within the next 6 months)
- •13. Known hypersensitivity to Ginkgo biloba extract, pentoxifylline or other methylxanthine substances, or to excipients contained in the tablets
- •14. 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)
- •15. Female patients of childbearing potential without safe contraception (hormonal contraception, oral or transdermal, is considered sufficiently safe; child-bearing potential can be denied in case of postmenopausal state for at least 2 years, hysterectomy, bilateral tubal ligation or bilateral oophorectomy)
研究者
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