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Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

NCT ID: NCT00525551

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Otosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Acetylcysteine

Intervention Type 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.

2

Group Type PLACEBO_COMPARATOR

Placebo (NaCl)

Intervention Type DRUG

300 mL 0.9% NaCl

Interventions

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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.

Intervention Type DRUG

Placebo (NaCl)

300 mL 0.9% NaCl

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Fridberger

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Bagger-Sjoback, M.D.,Ph.D.

Role: STUDY_CHAIR

Karolinska University Hospital

Anders Fridberger, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska University Hospital Huddinge

Huddinge, , Sweden

Site Status

Karolinska University Hospital, Dept. of Otorhinolaryngology

Stockholm, , Sweden

Site Status

Academic Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 25763866 (View on PubMed)

Other Identifiers

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EudraCT 2006-006243-31

Identifier Type: -

Identifier Source: secondary_id

KS-OAS1

Identifier Type: -

Identifier Source: org_study_id