Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal - Full Text View

Purpose

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	Intervention	Phase
Ear Infection Hearing Loss Vertigo	Drug: drops intilation (Taponoto ® ) Drug: drops intilation (Otocerum®) Drug: drops intilation (Placebo)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Dizziness and Vertigo Hearing Disorders and Deafness Potassium

Drug Information available for: Potassium bicarbonate Potassium carbonate Potassium chloride

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed [ Time Frame: 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

adverse effects [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]

Enrollment:	90
Study Start Date:	September 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2 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) 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of ear cerumen

Exclusion Criteria:

Infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765635

Locations

Spain
Hospital Clinic
Barcelona, Spain, 08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

More Information

Publications:

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.

Responsible Party:	Miguel Caballero / ENT specialist, Hospital clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00765635 History of Changes
Other Study ID Numbers:	CLO2008/4503
Study First Received:	October 2, 2008
Last Updated:	October 2, 2008
Health Authority:	Spain: Ministry of Health

Keywords provided by Hospital Clinic of Barcelona:

complete occlusion of the ear canal due to cerumen

Additional relevant MeSH terms:

Hearing Loss
Deafness
Vertigo
Otitis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases

Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases

ClinicalTrials.gov processed this record on June 18, 2013