Study to compare the treatment effects of Ginkgo biloba extract EGb 761® and Pentoxifylline in patients who suffer from tinnitus for more than three months and from psychological and social problems caused by the tinnitus

Not Applicable

Completed

• Conditions: Chronic or subchronic tinnitus; Ear, Nose and Throat; Tinnitus

• Registration Number: ISRCTN68772788
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-03
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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
5.1. Severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris
5.2. Decompensated congestive heart failure (NYHA stage IV)
5.3. Significant coronary sclerosis or history of myocardial infarction diastolic blood pressure above 115 mmHg
5.4. Hypotension with systolic blood pressure below 110 mmHg and/or diastolic blood pressure below 70 mmHg
5.5. 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 three 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
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; childbearing 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Abridged Tinnitus Questionnaire (Mini-TQ), measured at baseline (Day 0), Week 6 and Week 12 of treatment.<br>2. 11-Point Box Scales for tinnitus loudness and annoyance, measured with a daily diary from day -7 (screening visit) to Day 84 (final visit after 12 weeks of treatment)

Secondary Outcome Measures

Name	Time	Method
Efficacy:<br>1. Hospital Anxiety and Depression Scale (HADS) and Sheehan Disability Scale, both measured at baseline (Day 0), Week 6 and Week 12 of treatment<br>2. Pure Tone and Speech Audiometry, measured at Screening (Day -7) and Week 12 (after 12 weeks of treatment)<br><br>Safety:<br>1. Physical examination (at screening and week 12)<br>2. Otological examination (at screening and week 12)<br>3. Vital signs (at screening and week 12)<br>4. ECG (at screening and week 12)<br>5. Adverse events (at baseline and weeks 4, 6, 8 and 12)<br>6. Laboratory tests (at screening and week 12)