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Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

NCT ID: NCT00765635

Last Updated: 2008-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Ear Infection Hearing Loss Vertigo

Keywords

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complete occlusion of the ear canal due to cerumen

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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2

Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),

Group Type EXPERIMENTAL

drops intilation (Taponoto ® )

Intervention Type DRUG

four drops, unique doses

3

sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).

Group Type PLACEBO_COMPARATOR

drops intilation (Placebo)

Intervention Type DRUG

Placebo

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),

Group Type EXPERIMENTAL

drops intilation (Otocerum®)

Intervention Type DRUG

four drops, unique doses

Interventions

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drops intilation (Taponoto ® )

four drops, unique doses

Intervention Type DRUG

drops intilation (Otocerum®)

four drops, unique doses

Intervention Type DRUG

drops intilation (Placebo)

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of ear cerumen

Exclusion Criteria

* Infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital clinic of Barcelona

Locations

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Hospital Clinic

Barcelona, barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 15492164 (View on PubMed)

Other Identifiers

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CLO2008/4503

Identifier Type: -

Identifier Source: org_study_id