Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

NCT00525551 | Completed Phase 4

• 2 other identifiers: KS-OAS1EudraCT 2006-006243-31
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 3

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.

Conditions

Otosclerosis

Outcome Measures

Primary Outcomes (1)

• Hearing thresholds

  one year

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Acetylcysteine

2

PLACEBO COMPARATOR

Drug: Placebo (NaCl)

Interventions

Acetylcysteine 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.

1

Placebo (NaCl) DRUG

300 mL 0.9% NaCl

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otosclerosis where surgery is planned
• Air / bone gap larger than 20 dB
• Normal middle ear status

You may not qualify if:

• Hypersensitivity to acetylcysteine
• Deafness on the other ear
• Stapedotomy previously performed on the ear
• Pregnancy
• Asthma

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator
• AstraZeneca: collaborator

Study Sites (3)

Karolinska University Hospital Huddinge

Huddinge, SE-141 86, Sweden

Location

Karolinska University Hospital, Dept. of Otorhinolaryngology

Stockholm, SE-171 76, Sweden

Location

Academic Hospital

Uppsala, SE-75185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25763866 DERIVED

MeSH Terms

Conditions

Otosclerosis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Dan Bagger-Sjoback, M.D.,Ph.D.

  Karolinska University Hospital

  STUDY CHAIR

• Anders Fridberger, M.D.,Ph.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

SE (3)