Double-blind, randomized, placebo-controlled study on efficacy, safety and tolerability of ancrod in patients with sudden sensorineural hearing loss - n.a.

ordmark Arzneimittel GmbH & Co. KG0 sites115 target enrollmentJuly 2, 2012

Conditionssudden sensorineural hearing loss (SSHL)MedDRA version: 20.0Level: LLTClassification code 10040016Term: Sensorineural hearing lossSystem Organ Class: 100000004854 Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: sudden sensorineural hearing loss (SSHL)
Sponsor: ordmark Arzneimittel GmbH & Co. KG
Enrollment: 115
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 2, 2012

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ordmark Arzneimittel GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following inclusion criteria in order to be eligible for this study:
•1\.Unilateral idiopathic sudden sensorineural hearing loss \=30 dB in at least 2 consecutive frequencies in the affected ear or \=20 dB in 3 consecutive frequencies based upon evaluation of 8 frequencies, 0\.125, 0\.25, 0\.5, 1, 2, 4, 6, and 8 kHz, compared to the contralateral ear.
•2\.Symmetric hearing prior to onset of SSHL, according to patient’s recollection.
•3\. Patients with hearing loss not greater than 90dB at 0\.125, 0\.25, 0\.5, 1, 2, 4, 6, and 8 kHz.
•4\.Enrollment has to be accomplished within 7 days after SSHL onset.
•5\.Male or female aged \=18 to \=70 years.
•6\.Women of childbearing potential who are sexually active with opposite partners have to perform adequate contraception with a combination of a highly effective method of birth control and additional barrier contraception.
•\[Highly effective method of birth control is defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly for the entire study duration: combined (oestrogen and gestagen) oral contraceptives, hormone implants, hormone injectables, or hormone containing intrauterine device that needed to be in place for a period of at least 2 months prior to screening. Additional barrier contraception (at least the following methods are allowed: condom of the male, diaphragm with spermicide, portio cap with spermicide) has to be used for the duration of the trial, defined as from the time of screening to at least 10 days after day 6 (Visit 4\). A single barrier method is not acceptable. Women of non\-childbearing potential can be included if surgically sterile (documented complete hysterectomy or bi\-tubal ligations) or post\-menopausal \>1 year.]
•7\.Men of reproductive potential must use condoms. In addition, the female partner should also be on a safe hormonal contraception (e.g. combined oral contraceptives, hormone implants, hormone injectables or hormone containing intrauterine device) or use a barrier contraception (e.g. intrauterine device, diaphragm or portio cap with spermicide), if she is of childbearing potential.
•8\.Ability to understand and to follow the study protocol.

Exclusion Criteria

•1\.Pregnant or breast\-feeding female.
•2\.positive pregnancy test before receiving study drug
•3\.Body weight \>140 kg.
•4\.Bilateral SSHL.
•5\.Incomplete recovery after previous SSHL, when symetric hearing loss was not reached again, according to patient´s recollection
•6\.Due to history of physical efforts suspected perilymph fistula or membrane rupture.
•7\.Previously existing, known retrocochlear hearing loss.
•8\.Any history of any ear operation or local inflammatory disease in the past one year
•9\.History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL.
•10\.History of Menière’s disease, autoimmune hearing loss, radiation\-induced hearing loss, endolymphatic hydrops.