🇺🇸 FDA
Pipeline program

ACIDE FOLIQUE CCD 5 mg, comprimé, PLACEBO D'ASPIRINE PROTECT, ASPIRINE PROTECT 100 mg, comprimé gastro-résistant, PLACEBO D'ACIDE FOLIQUE

APHP230836

Phase 3 small_molecule active

Quick answer

ACIDE FOLIQUE CCD 5 mg, comprimé, PLACEBO D'ASPIRINE PROTECT, ASPIRINE PROTECT 100 mg, comprimé gastro-résistant, PLACEBO D'ACIDE FOLIQUE for Patients presenting to ENT emergencies with a unilateral sudden sensorineural hearing loss (SSNHL). SSNHL is defined according to the American ENT society guidelines criteria as a subset of SSNHL that is sensorineural in nature, occurs within a 72 hour window, and consists of a decrease in hearing of ≥30 decibels affecting at least 3 consecutive frequencies: 1. A history of an idiopathic and unilateral sudden decrease in hearing > 72 hours and <15 days. 2. A unilateral sensorineural hearing loss demonstrable on a pure‐tone audiogram at the time of entry into the trial. 3. No other neurological signs except the eight cranial nerve defect; no other types of hearing loss as conductive forms of hearing impairment. 4. No history of fluctuating sensorineural hearing loss or otologic disease. is a Phase 3 program (small_molecule) at Pari Pharma GmbH with 1 ClinicalTrials.gov record(s).

Program details

Company
Pari Pharma GmbH
Indication
Patients presenting to ENT emergencies with a unilateral sudden sensorineural hearing loss (SSNHL). SSNHL is defined according to the American ENT society guidelines criteria as a subset of SSNHL that is sensorineural in nature, occurs within a 72 hour window, and consists of a decrease in hearing of ≥30 decibels affecting at least 3 consecutive frequencies: 1. A history of an idiopathic and unilateral sudden decrease in hearing > 72 hours and <15 days. 2. A unilateral sensorineural hearing loss demonstrable on a pure‐tone audiogram at the time of entry into the trial. 3. No other neurological signs except the eight cranial nerve defect; no other types of hearing loss as conductive forms of hearing impairment. 4. No history of fluctuating sensorineural hearing loss or otologic disease.
Phase
Phase 3
Modality
small_molecule
Status
active

Clinical trials