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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)

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

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