Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
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|ClinicalTrials.gov Identifier: NCT00765635|
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : October 3, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Ear Infection Hearing Loss Vertigo||Drug: drops intilation (Taponoto ® ) Drug: drops intilation (Otocerum®) Drug: drops intilation (Placebo)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||October 2008|
Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),
Drug: drops intilation (Taponoto ® )
four drops, unique doses
Placebo Comparator: 3
sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).
Drug: drops intilation (Placebo)
Experimental: 1: Chlorobutanol
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),
Drug: drops intilation (Otocerum®)
four drops, unique doses
- proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed [ Time Frame: 2008 ]
- adverse effects [ Time Frame: 2008 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765635
|Barcelona, Spain, 08036|