Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis
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StatusCompleted
Sponsors
Karolinska University Hospital
Collaborators
Karolinska Institutet
AstraZeneca
CLINICAL TRIAL: NCT00525551
BioSeek: nct00525551
Keywords
Abstract
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.
Dates
| Last Verified: | 08/31/2013 |
| First Submitted: | 09/03/2007 |
| Estimated Enrollment Submitted: | 09/03/2007 |
| First Posted: | 09/05/2007 |
| Last Update Submitted: | 09/09/2013 |
| Last Update Posted: | 09/10/2013 |
| Actual Study Start Date: | 08/31/2007 |
| Estimated Primary Completion Date: | 03/31/2013 |
| Estimated Study Completion Date: | 03/31/2013 |
Condition or disease
Otosclerosis
Intervention/treatment
Drug: 1
Drug: 2
Phase
Phase 4
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 1 | Drug: 1 150 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 Comparator: 2 | Drug: 2 300 mL 0.9% NaCl |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Hearing thresholds [one year]
