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| Sponsor: | Karolinska University Hospital |
|---|---|
| Collaborators: |
Karolinska Institutet AstraZeneca |
| Information provided by: | Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT00525551 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Otosclerosis |
Drug: Acetylcysteine Drug: Placebo (NaCl) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Acetylcystein Vid Stapedotomi |
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
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.
|
| 2: Placebo Comparator |
Drug: Placebo (NaCl)
300 mL 0.9% NaCl
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dan Bagger-Sjoback, M.D., Ph.D. | +46-8-51776032 | dan.bagger-sjoback@karolinska.se |
| Contact: Carina Jankevics, R.N. | +46-8-51776030 | carina.jankevics@karolinska.se |
| Sweden | |
| Karolinska University Hospital, Dept. of Otorhinolaryngology | Recruiting |
| Stockholm, Sweden, SE-171 76 | |
| Contact: Dan Bagger-Sjoback, M.D.,Ph.D. +46-8-51776032 dan.bagger-sjoback@karolinska.se | |
| Sub-Investigator: Malou Hultcrantz, M.D.,Ph.D. | |
| Sub-Investigator: Georgios Papatziamos, M.D. | |
| Sub-Investigator: Sten Hellstrom, M.D.,Ph.D. | |
| Academic Hospital | Recruiting |
| Uppsala, Sweden, SE-75185 | |
| Contact: Karin Strömbäck, M.D., Ph.D. +46186119449 karins.stromback@akademiska.se | |
| Contact: Ann-Cathrine Chkalikoff, R.N. +46186119450 ann-cathrine.chkalikoff@akademiska.se | |
| Principal Investigator: Karin Strömbäck, M.D.,Ph.D. | |
| Karolinska University Hospital Huddinge | Recruiting |
| Huddinge, Sweden, SE-141 86 | |
| Contact: Christina Larsson, M.D.,Ph.D. +46858580000 christina.larsson@karolinska.se | |
| Contact: Lars-Olaf Cardell, M.D.,Ph.D. +46858581435 lars-olaf.cardell@ki.se | |
| Sub-Investigator: Christina Larsson, M.D.,Ph.D. | |
| Principal Investigator: Lars-Olaf Cardell, M.D.,Ph.D. | |
| Study Chair: | Dan Bagger-Sjoback, M.D.,Ph.D. | Karolinska University Hospital |
| Principal Investigator: | Anders Fridberger, M.D.,Ph.D. | Karolinska Institutet |
More Information
| Responsible Party: | Karolinska University Hospital ( Dr. Dan Bagger-Sjöbäck ) |
| Study ID Numbers: | KS-OAS1, EudraCT 2006-006243-31 |
| Study First Received: | September 4, 2007 |
| Last Updated: | March 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00525551 History of Changes |
| Health Authority: | Sweden: Medical Products Agency |
|
Anti-Infective Agents Respiratory System Agents Otorhinolaryngologic Diseases Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Otosclerosis Protective Agents Ear Diseases |
Antiviral Agents Pharmacologic Actions Expectorants Therapeutic Uses Free Radical Scavengers Acetylcysteine N-monoacetylcystine Antidotes |
