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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-006243-31 |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylcysteine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing thresholds | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Bagger-Sjoback, M.D.,Ph.D. | Karolinska University Hospital | Study Chair |
| Anders Fridberger, M.D.,Ph.D. | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital Huddinge | Huddinge | SE-141 86 | Sweden | |||
| Karolinska University Hospital, Dept. of Otorhinolaryngology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25763866 | Derived | Bagger-Sjoback D, Stromback K, Hakizimana P, Plue J, Larsson C, Hultcrantz M, Papatziamos G, Smeds H, Danckwardt-Lilliestrom N, Hellstrom S, Johansson A, Tideholm B, Fridberger A. A randomised, double blind trial of N-Acetylcysteine for hearing protection during stapes surgery. PLoS One. 2015 Mar 12;10(3):e0115657. doi: 10.1371/journal.pone.0115657. eCollection 2015. |
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| ID | Term |
|---|---|
| D010040 | Otosclerosis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo (NaCl) | Drug | 300 mL 0.9% NaCl |
|
| Stockholm |
| SE-171 76 |
| Sweden |
| Academic Hospital | Uppsala | SE-75185 | Sweden |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |