Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-31 @ 11:51 AM
Study NCT ID:
NCT00525551
Status:
COMPLETED
Last Update Posted:
2013-09-11
First Post:
2007-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010040', 'term': 'Otosclerosis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-10', 'studyFirstSubmitDate': '2007-09-04', 'studyFirstSubmitQcDate': '2007-09-04', 'lastUpdatePostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing thresholds', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Otosclerosis']}, 'referencesModule': {'references': [{'pmid': '25763866', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAnimal 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Otosclerosis where surgery is planned\n* Air / bone gap larger than 20 dB\n* Normal middle ear status\n\nExclusion Criteria:\n\n* Hypersensitivity to acetylcysteine\n* Deafness on the other ear\n* Stapedotomy previously performed on the ear\n* Pregnancy\n* Asthma'}, 'identificationModule': {'nctId': 'NCT00525551', 'briefTitle': 'Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Acetylcystein Vid Stapedotomi', 'orgStudyIdInfo': {'id': 'KS-OAS1'}, 'secondaryIdInfos': [{'id': 'EudraCT 2006-006243-31'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Acetylcysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo (NaCl)']}], 'interventions': [{'name': 'Acetylcysteine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['1']}, {'name': 'Placebo (NaCl)', 'type': 'DRUG', 'description': '300 mL 0.9% NaCl', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-141 86', 'city': 'Huddinge', 'country': 'Sweden', 'facility': 'Karolinska University Hospital Huddinge', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}, {'zip': 'SE-171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital, Dept. of Otorhinolaryngology', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'SE-75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Academic Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Dan Bagger-Sjoback, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska University Hospital'}, {'name': 'Anders Fridberger, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Anders Fridberger', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}