Clinical study to investigate the treatment effects of a Ginkgo biloba extract in comparison to the standard medication Pentoxifylline in patients with chronic or subchronic tinnitus (ear noises)

• Conditions: Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]; chronic or sub-chronic tinnitus; MedDRA version: 14.1Level: PTClassification code 10043882Term: TinnitusSystem Organ Class: 10013993 - Ear and labyrinth disorders

• Registration Number: EUCTR2011-004697-28-CZ
• Lead Sponsor: Dr. W. Schwabe GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-27
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified