Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
Primary Purpose
Ear Infection, Hearing Loss, Vertigo
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
drops intilation (Taponoto ® )
drops intilation (Otocerum®)
drops intilation (Placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Ear Infection focused on measuring complete occlusion of the ear canal due to cerumen
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of ear cerumen
Exclusion Criteria:
- Infection
Sites / Locations
- Hospital Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
2
3
1: Chlorobutanol
Arm Description
Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),
sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).
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),
Outcomes
Primary Outcome Measures
proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed
Secondary Outcome Measures
adverse effects
Full Information
NCT ID
NCT00765635
First Posted
October 2, 2008
Last Updated
October 2, 2008
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00765635
Brief Title
Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
Official Title
Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Removal 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Infection, Hearing Loss, Vertigo
Keywords
complete occlusion of the ear canal due to cerumen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).
Arm Title
1: Chlorobutanol
Arm Type
Experimental
Arm 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),
Intervention Type
Drug
Intervention Name(s)
drops intilation (Taponoto ® )
Intervention Description
four drops, unique doses
Intervention Type
Drug
Intervention Name(s)
drops intilation (Otocerum®)
Intervention Description
four drops, unique doses
Intervention Type
Drug
Intervention Name(s)
drops intilation (Placebo)
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed
Time Frame
2008
Secondary Outcome Measure Information:
Title
adverse effects
Time Frame
2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of ear cerumen
Exclusion Criteria:
Infection
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
15492164
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.
Results Reference
background
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Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
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