Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

Phase 4

Completed

• Conditions: Otosclerosis
• Interventions: Drug: Placebo (NaCl); Drug: Acetylcysteine

• Registration Number: NCT00525551
• Lead Sponsor: Karolinska University Hospital

Brief Summary

In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage.

Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-10
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Otosclerosis where surgery is planned
• Air / bone gap larger than 20 dB
• Normal middle ear status

Exclusion Criteria

• Hypersensitivity to acetylcysteine
• Deafness on the other ear
• Stapedotomy previously performed on the ear
• Pregnancy
• Asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo (NaCl)	-
1	Acetylcysteine	-

Primary Outcome Measures

Name	Time	Method
Hearing thresholds	one year

Trial Locations

Locations (3)

Karolinska University Hospital Huddinge; 🇸🇪 Huddinge, Sweden

Karolinska University Hospital, Dept. of Otorhinolaryngology; 🇸🇪 Stockholm, Sweden

Academic Hospital; 🇸🇪 Uppsala, Sweden