Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis
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|ClinicalTrials.gov Identifier: NCT00525551|
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : September 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Otosclerosis||Drug: Acetylcysteine Drug: Placebo (NaCl)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Acetylcystein Vid Stapedotomi|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
|Active Comparator: 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: Placebo (NaCl)
300 mL 0.9% NaCl
- Hearing thresholds [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525551
|Karolinska University Hospital Huddinge|
|Huddinge, Sweden, SE-141 86|
|Karolinska University Hospital, Dept. of Otorhinolaryngology|
|Stockholm, Sweden, SE-171 76|
|Uppsala, Sweden, SE-75185|
|Study Chair:||Dan Bagger-Sjoback, M.D.,Ph.D.||Karolinska University Hospital|
|Principal Investigator:||Anders Fridberger, M.D.,Ph.D.||Karolinska Institutet|