Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis
This study is currently recruiting participants.
Verified January 2012 by Karolinska University Hospital
Sponsor:
Karolinska University Hospital
Collaborators:
Karolinska Institutet
AstraZeneca
Information provided by (Responsible Party):
Anders Fridberger, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00525551
First received: September 4, 2007
Last updated: January 4, 2012
Last verified: January 2012
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Acetylcystein Vid Stapedotomi |
Resource links provided by NLM:
Further study details as provided by Karolinska University Hospital:
Primary Outcome Measures:
- Hearing thresholds [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
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.
|
| Placebo Comparator: 2 |
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 |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525551
Contacts
| 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 |
Locations
| Sweden | |
| 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. | |
| 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. | |
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
AstraZeneca
Investigators
| Study Chair: | Dan Bagger-Sjoback, M.D.,Ph.D. | Karolinska University Hospital |
| Principal Investigator: | Anders Fridberger, M.D.,Ph.D. | Karolinska Institutet |
More Information
No publications provided
| Responsible Party: | Anders Fridberger, Dr., Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT00525551 History of Changes |
| Other Study ID Numbers: | KS-OAS1, EudraCT 2006-006243-31 |
| Study First Received: | September 4, 2007 |
| Last Updated: | January 4, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Otosclerosis Ear Diseases Otorhinolaryngologic Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 16, 2013