Chronic tinnitus Ear, Nose and Throat Chronic tinnitus
Conditions
Interventions
The trial involves 175 participants (male and female). The trial duration per participant is maximum of 26 weeks. Every patient receives 120 mg EGb 761® film coated tablets twice daily during the 24 t
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effectiveness is measured using the Tinnitus Questionnaire (TQ) at baseline, 12 and 24 weeks 2. Effectiveness is measured using the Tinnitus Handicap Inventory (THI) at baseline, 12 and 24 weeks 3. Effectiveness is measured using the 11-point box scales for tinnitus loudness and annoyance at baseline, 12 and 24 weeks 4. Effectiveness is measured using the Pure tone audiometry at screening at 24 weeks 5. Effectiveness is measured using the Determination of tinnitus loudness at screening at 24 weeks 6. Anxiety and Depression are measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 12 and 24 weeks 7. Stress is measured using the Perceived Stress Questionnaire (PSQ) at baseline, 12 and 24 weeks 8. Effectiveness is measured using the Sheehan Disability Scale (SDS) at baseline, 12 and 24 weeks | — |
| 1. Effectiveness is measured using the Tinnitus Questionnaire (TQ) at baseline, 12 and 24 weeks 2. Effectiveness is measured using the Tinnitus Handicap Inventory (THI) at baseline, 12 and 24 weeks 3. Effectiveness is measured using the 11-point box scales for tinnitus loudness and annoyance at baseline, 12 and 24 weeks 4. Effectiveness is measured using the Pure tone audiometry at screening at 24 weeks 5. Effectiveness is measured using the Determination of tinnitus loudness at screening at 24 weeks 6. Anxiety and Depression are measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 12 and 24 weeks 7. Stress is measured using the Perceived Stress Questionnaire (PSQ) at baseline, 12 and 24 weeks 8. Effectiveness is measured using the Sheehan Disability Scale (SDS) at baseline, 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serious (SAEs) and non-serious adverse events (AEs) are spontaneously reported by the patient or observed by the investigator continuously throughout the whole trial 2. Vital signs (blood pressure, pulse rate) will be measured in sitting position at baseline, 12 and 24 weeks 3. Safety laboratory results (hematology, coagulation, clinical chemistry and urinalysis) are measured via blood and urine samples at screening and 24 weeks | — |
| 1. Serious (SAEs) and non-serious adverse events (AEs) are spontaneously reported by the patient or observed by the investigator continuously throughout the whole trial 2. Vital signs (blood pressure, pulse rate) will be measured in sitting position at baseline, 12 and 24 weeks 3. Safety laboratory results (hematology, coagulation, clinical chemistry and urinalysis) are measured via blood and urine samples at screening and 24 weeks | — |
Countries
Poland
Contacts
Public ContactAnnette Wassmer
Outcome results
None listed