Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Hearing Loss Clinical Trial

Official title:

Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765635
• Other study ID #: CLO2008/4503
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2008
• Last updated: October 2, 2008
• Start date: September 2008

Study information

• Verified date: October 2008
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of ear cerumen

Exclusion Criteria:

• Infection

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ear Infection
• Hearing Loss
• Otitis
• Vertigo

Intervention

Drug:
• drops intilation (Taponoto ® )
four drops, unique doses
• drops intilation (Otocerum®)
four drops, unique doses
• drops intilation (Placebo)
Placebo

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed		2008	No
Secondary	adverse effects		2008	Yes