Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00765635
First received: October 2, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 2, 2008
October 2, 2008
September 2008
October 2008   (final data collection date for primary outcome measure)
proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed [ Time Frame: 2008 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
adverse effects [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Ear Infection
  • Hearing Loss
  • Vertigo
  • Drug: drops intilation (Taponoto ® )
    four drops, unique doses
  • Drug: drops intilation (Otocerum®)
    four drops, unique doses
  • Drug: drops intilation (Placebo)
    Placebo
  • Experimental: 2
    Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),
    Intervention: Drug: drops intilation (Taponoto ® )
  • Placebo Comparator: 3
    sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).
    Intervention: Drug: drops intilation (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),
    Intervention: Drug: drops intilation (Otocerum®)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
Not Provided
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of ear cerumen

Exclusion Criteria:

  • Infection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00765635
CLO2008/4503
Yes
Miguel Caballero / ENT specialist, Hospital clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Not Provided
Hospital Clinic of Barcelona
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP