Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

NCT00765635 | Completed Phase 4 DMC

• 1 other identifier: CLO2008/4503
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ear Infection; Hearing Loss; Vertigo

Keywords

complete occlusion of the ear canal due to cerumen

Outcome Measures

Primary Outcomes (1)

• proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed

  2008

Secondary Outcomes (1)

• adverse effects

  2008

Study Arms (3)

2

EXPERIMENTAL

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

Drug: drops intilation (Taponoto ® )

3

PLACEBO COMPARATOR

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

Drug: drops intilation (Placebo)

1: Chlorobutanol

EXPERIMENTAL

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®)

Interventions

drops intilation (Taponoto ® ) DRUG

four drops, unique doses

2

drops intilation (Otocerum®) DRUG

four drops, unique doses

1: Chlorobutanol

drops intilation (Placebo) DRUG

Placebo

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of ear cerumen

You may not qualify if:

• Infection

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 15492164 BACKGROUND

MeSH Terms

Conditions

Otitis; Hearing Loss; Vertigo

Interventions

Otocerum

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2008
• Last Updated: October 3, 2008

Record last verified: 2008-10

Locations

ES (1)