Noise induced hearing impairment (temporarily)
Conditions
Interventions
Trade Name: Tebonin® intens 120 mg
Product Name: EGb 761®
Product Code: EGb 761®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EGb761
CAS Number: 122933-57-7
Current Sponsor code: EG
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. healthy, normal hearing men aged between 18 and 25 2. written informed consent 3. Willingness and ability to perform all study relevant tests 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 202 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. anamnestically noted hearing impairment, sudden deafness, accoustic trauma 2. Tinnitus 3. Estimated noise exposition (job, leisure) aboce the mean 85 dB 8 hours 5 days a week 4. at the screening evaluated impairment of outer, middle or inner ear or hearing impairment such as middle ear effusion, auditory canal and/or tubal ventilation disorder, ear surgery in the past, horizontal timpani tube 5. haemorrhagic diathesis, coagulation disorder 6. Diseases influencing resorption 7. Chronic, severe or acute gerneral diseases within 4 weeks prior to study start 8. hypersensitivity against ingredients of the study medication 9. Acute or chronic otological, neurological or psychiatric diseases within 12 weeks prior to study start 10. Clinically relevant internal diseases with the exception of a) sufficient and stably treated thyroid dysfunction or struma 11. clinically significant ECG -or laboratory abnormalities 12. Substance misuse or addiction current or in medical history 13. Participation in another clinical trial within 12 weeks prior to study start 14. regular intake if medication, food supplements, vitamines or mineral products with the exceptions of a. thyroid hormones 15. Concomitant medications from following substance classes a. corticosteroides (systemic) b.ASS or NSAR c. potentially ototoxic antibiotics d. Thromocyte aggregation inhibitors or anticoagulants e. Psychopharmaca (anti depressivs, anxiolytics, tranquilizer, hypnotics) f. Herbal drugs or food supplements on a herbal basis g. Minerals or vitamines h. Antihistaminics or Antiemetics with effect on the central nervous system 16. Intake of Ginkgo Biloba product within 8 weeks prior to study start 17. Planned surgery or hospitalization during study period 18. Further facts, which question a study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Mean increase of the auditory threshold at frequencies 3, 4, 6,8 , 10, 11.2 and 12.5 kHz between 1 and 8 minutes after acoustic irradiation;Timepoint(s) of evaluation of this end point: The time of evaluation is visit 3 (after 26-30 days of study medication intake).;Main Objective: Evaluation of the efficacy of EGb 761® against temporary hearing impairment due to noise (bilaterally 5 minutes 110 dB broadband noise) in healthy subjects.;Secondary Objective: Tolerability and safety of EGb761(R) in healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Decrease of the distorsion product-OAE 2) Decrease of the contralateral suppression of the TEOAE 3) Decrease of klick-evoked OAE amplitude (TEOAE) 4) proportion of subjects with increased auditory threshold > 5dB at the frequencies 3, 4, 6, 8, 10, 11.2 or 12.5 kHz 5) Adverse Events;Timepoint(s) of evaluation of this end point: 1) Visit 3 (after 26-30 days of study medication intake) 1-10 minutes after acoustic irradiation, and visit 4 (after 4 weeks). 2) Visit 3 (after 26-30 days of study medication intake) 1-10 minutes after acoustic irradiation, and visit 4 (after 4 weeks). 3) Visit 3 (after 26-30 days of study medication intake) 1-10 minutes after acoustic irradiation, and visit 4 (after 4 weeks). 4) Visit 4 (after 4 weeks). 5) Throughout the whole study period. | — |
Countries
Germany
Contacts
Public ContactAbteilung Medizinische Wissenschaft
Dr. Willmar Schwabe GmbH & Co. KG
Outcome results
None listed