Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

Otosclerosis Clinical Trial

Official title:

Acetylcystein Vid Stapedotomi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525551
• Other study ID #: KS-OAS1
• Secondary ID: EudraCT 2006-006
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2007
• Last updated: September 10, 2013
• Start date: September 2007
• Est. completion date: April 2013

Study information

• Verified date: September 2013
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otosclerosis

Intervention

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.
• Placebo (NaCl)
300 mL 0.9% NaCl

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital Huddinge	Huddinge
Sweden	Karolinska University Hospital, Dept. of Otorhinolaryngology	Stockholm
Sweden	Academic Hospital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	AstraZeneca, Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing thresholds		one year	No