chronic or sub-chronic tinnitus MedDRA version: 14.1 Level: PT Classification code 10043882 Term: Tinnitus System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Interventions
Trade Name: Tebonin® intens 120 mg
Product Name: Ginkgo biloba special extract EGb 761®
Product Code: EGb 761®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NA
CAS Number: 90045-36-6
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Sponsors
Dr. W. Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the treatment effects of Ginkgo biloba extract EGb 761® and pentoxifylline in patients with sub-chronic or chronic tinnitus focussing on psycho-social problems;Secondary Objective: To underline the safety and tolerability of EGb 761®;Primary end point(s): the changes of the 11-point box scales for tinnitus loudness and annoyance and the changes of the Mini-TQ total score during the 12 weeks of treatment; ;Timepoint(s) of evaluation of this end point: comparison after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Czech Republic
Contacts
Public ContactClinical Research
Dr. W. Schwabe GmbH & Co. KG
Outcome results
None listed