Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 10:37 PM
Study NCT ID:
NCT00765635
Status:
COMPLETED
Last Update Posted:
2008-10-03
First Post:
2008-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D014717', 'term': 'Vertigo'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552152', 'term': 'Otocerum'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'lastUpdateSubmitDate': '2008-10-02', 'studyFirstSubmitDate': '2008-10-02', 'studyFirstSubmitQcDate': '2008-10-02', 'lastUpdatePostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed', 'timeFrame': '2008'}], 'secondaryOutcomes': [{'measure': 'adverse effects', 'timeFrame': '2008'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['complete occlusion of the ear canal due to cerumen'], 'conditions': ['Ear Infection', 'Hearing Loss', 'Vertigo']}, 'referencesModule': {'references': [{'pmid': '15492164', 'type': 'BACKGROUND', 'citation': 'Roland PS, Eaton DA, Gross RD, Wall GM, Conroy PJ, Garadi R, Lafontaine L, Potts S, Hogg G. Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products. Arch Otolaryngol Head Neck Surg. 2004 Oct;130(10):1175-7. doi: 10.1001/archotol.130.10.1175.'}]}, 'descriptionModule': {'briefSummary': "Accumulation of cerumen in the external ear canal is a common problem. The presence of cerumen not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections.\n\nRemoval of cerumen is facilitated by the use of a variety of ceruminolytics, or wax solvents. The current study was designed to evaluate the ceruminolytic effects of a single, brief application of the two most frequently used products in the investigators area, containing chlorobutanol or potassium carbonate with or without irrigation in the primary care setting in a randomized, single-blind trial. To our knowledge, this is the first randomized study comparing ceruminolytics with chlorobutanol versus potassium carbonate.", 'detailedDescription': "INTERVENTIONS: Subjects were randomly assigned to one of three different treatments: Otocerum®; Taponoto ®, and a control group with sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain). The test medication was instilled into an occluded ear for 15 minutes. Following this treatment, the subject's ear was irrigated with 50 mL of water. The main outcome was the proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of ear cerumen\n\nExclusion Criteria:\n\n* Infection'}, 'identificationModule': {'nctId': 'NCT00765635', 'briefTitle': 'Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal', 'orgStudyIdInfo': {'id': 'CLO2008/4503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),', 'interventionNames': ['Drug: drops intilation (Taponoto ® )']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).', 'interventionNames': ['Drug: drops intilation (Placebo)']}, {'type': 'EXPERIMENTAL', 'label': '1: Chlorobutanol', 'description': 'ceruminolytic product, Otocerum® (Chlorobutanol 50 mg/1 ml, phenol 10 mg/1 ml, turpentine essence 0.15 ml/1 ml, ethyl alcohol; Reig Jofre laboratories, Barcelona, Spain),', 'interventionNames': ['Drug: drops intilation (Otocerum®)']}], 'interventions': [{'name': 'drops intilation (Taponoto ® )', 'type': 'DRUG', 'description': 'four drops, unique doses', 'armGroupLabels': ['2']}, {'name': 'drops intilation (Otocerum®)', 'type': 'DRUG', 'description': 'four drops, unique doses', 'armGroupLabels': ['1: Chlorobutanol']}, {'name': 'drops intilation (Placebo)', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Miguel Caballero / ENT specialist', 'oldOrganization': 'Hospital clinic of Barcelona'}}}}