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Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Completed
CT.gov ID
NCT00765635
Collaborator
(none)
90
Enrollment
1
Location
3
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: drops intilation (Taponoto ® )
  • Drug: drops intilation (Otocerum®)
  • Drug: drops intilation (Placebo)
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed [2008]

Secondary Outcome Measures

  1. adverse effects [2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical diagnosis of ear cerumen
Exclusion Criteria:
  • Infection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinic Barcelona Spain 08036

Sponsors and Collaborators

  • Hospital Clinic of Barcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00765635
Other Study ID Numbers:
  • CLO2008/4503
First Posted:
Oct 3, 2008
Last Update Posted:
Oct 3, 2008
Last Verified:
Oct 1, 2008
Keywords provided by , ,
complete occlusion of the ear canal due to cerumen
Additional relevant MeSH terms:
Hearing Loss
Vertigo
Otitis

Study Results

No Results Posted as of Oct 3, 2008