Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss

Nordmark Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hearing Disorders; Ear Diseases; Hearing Loss; Deafness; Hearing Loss, Sensorineural

Treatments: Drug: Saline solution; Drug: Ancrod

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01621256

2012-000066-37 (EudraCT Number)

NM-V-101

Details and patient eligibility

About

The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).

Enrollment: 31 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB
• Symmetric hearing prior to onset of SSHL
• Enrollment has to be accomplished within 7 days after SSHL onset

Exclusion criteria

• Bilateral SSHL
• Incomplete recovery after previous SSHL
• Previously existing, known retrocochlear hearing loss
• Any history of any ear operation or local inflammatory disease in the past one year
• History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL
• History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
• Treatment with steroids for any reason within the preceding 30 days.
• Body weight > 140 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Ancrod

Experimental group

Description:

Ancrod

Treatment:

Drug: Ancrod

Saline solution

Placebo Comparator group

Description:

Saline solution

Treatment:

Drug: Saline solution