Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00525551
• Collaborator: Karolinska Institutet (Other), AstraZeneca (Industry)
• Enrollment: 152
• Locations: 3
• Arms: 2
• Duration (Months): 67
• Patients Per Site: 50.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Sep 1, 2007
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hearing thresholds [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital Huddinge	Huddinge		Sweden	SE-141 86
2	Karolinska University Hospital, Dept. of Otorhinolaryngology	Stockholm		Sweden	SE-171 76
3	Academic Hospital	Uppsala		Sweden	SE-75185

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anders Fridberger, Dr., Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT00525551
• Other Study ID Numbers: KS-OAS1; EudraCT 2006-006243-31
• First Posted: Sep 6, 2007
• Last Update Posted: Sep 11, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Otosclerosis; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Sep 11, 2013