Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

PHASE4CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Otosclerosis
Interventions
DRUG

Acetylcysteine

150 mg / kg body weight. Drug is dissolved in NaCl to a final volume of 300 mL. This volume is infused starting one hour prior to surgery, and continued 1 hour after the end of surgery.

DRUG

Placebo (NaCl)

300 mL 0.9% NaCl

Trial Locations (3)

SE-141 86

Karolinska University Hospital Huddinge, Huddinge

SE-171 76

Karolinska University Hospital, Dept. of Otorhinolaryngology, Stockholm

SE-75185

Academic Hospital, Uppsala

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Karolinska Institutet

OTHER

collaborator

AstraZeneca

INDUSTRY

lead

Karolinska University Hospital

OTHER