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Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525551
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : September 11, 2013
Karolinska Institutet
Information provided by (Responsible Party):
Anders Fridberger, Karolinska University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acetylcystein Vid Stapedotomi
Study Start Date : September 2007
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Hearing thresholds [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00525551

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Karolinska University Hospital Huddinge
Huddinge, Sweden, SE-141 86
Karolinska University Hospital, Dept. of Otorhinolaryngology
Stockholm, Sweden, SE-171 76
Academic Hospital
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
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Study Chair: Dan Bagger-Sjoback, M.D.,Ph.D. Karolinska University Hospital
Principal Investigator: Anders Fridberger, M.D.,Ph.D. Karolinska Institutet

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anders Fridberger, Dr., Karolinska University Hospital Identifier: NCT00525551     History of Changes
Other Study ID Numbers: KS-OAS1
EudraCT 2006-006243-31
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Ear Diseases
Otorhinolaryngologic Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs