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

Phase 2

Completed

• Conditions: Chronic tinnitus; Ear, Nose and Throat

• Registration Number: ISRCTN83863387
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-14
• Study Completion: 2017-12-19
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

1. Outpatient male or female patient at least 18 years old
2. Chronic tinnitus
2.1. May be unilateral or bilateral, with or without concomitant hearing loss
2.2. Grade according to Biesinger is 2 or 3*
2.3. 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.

Exclusion Criteria

1. Participation in another experimental drug trial at the same time or within the past 4 weeks before the 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 the baseline visit
4. Gingko biloba preparation for any reason taken currently or within 4 weeks before the baseline visit
5. Cognitive behavioral therapy or tinnitus retraining therapy started within 6 months prior to the 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:
8.1. Severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris
8.2. Decompensated congestive heart failure (NYHA stage IV)
8.3. Uncontrolled hypertension with systolic blood pressure above 180 mmHg and / or diastolic blood pressure above 115 mmHg
8.4. 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 the 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, mea

Study & Design

• Study Type: Interventional
• Study Design: Not specified