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.
- Conditions
- Chronic TinnitusMedDRA version: 20.0Level: PTClassification code 10043882Term: TinnitusSystem Organ Class: 10013993 - Ear and labyrinth disordersTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2016-000315-32-PL
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 175
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Primary end point(s): Effectiveness:<br>•Tinnitus Questionnaire (TQ; Hallam, Goebel & Hiller)<br>•Tinnitus Handicap Inventory (THI; Newman et al.)<br>•11-point box scales for tinnitus loudness and annoyance<br>•Pure tone audiometry<br>•Determination of tinnitus loudness<br>;Timepoint(s) of evaluation of this end point: Week 12 Visit and Week 24 Visit.<br><br>All analyses will be done at the end of the trial.;Main Objective: • To explore whether causes, risk factors, chronicity, characteristics of tinnitus and accompanying features influence the treatment effect of EGb 761® in terms of improvement and response rates<br>• To identify groups of patients that benefit most of EGb 761®
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety:<br>• Serious adverse events (SAEs) and non-serious adverse events<br>• Vital signs<br>• Safety laboratory results;Timepoint(s) of evaluation of this end point: Serious adverse events (SAEs) and non-serious adverse events thoughout the whole trial<br>Vital signs and safety laboratory results: Week 12 Visit and Week 24 Visit.<br><br>All analyses will be done at the end of the trial.