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Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

NCT00525551 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2013-09-11

No results posted yet for this study

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.

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

Sponsors & Collaborators

Principal Investigators

  • Dan Bagger-Sjoback, M.D.,Ph.D. · Karolinska University Hospital

  • Anders Fridberger, M.D.,Ph.D. · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525551 on ClinicalTrials.gov