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| Sponsored by: |
Hospital Clinic of Barcelona |
|---|---|
| Information provided by: | Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00765635 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ear Infection Hearing Loss Vertigo |
Drug: drops intilation (Taponoto ® ) Drug: drops intilation (Otocerum®) Drug: drops intilation (Placebo) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal |
| Enrollment: | 90 |
| Study Start Date: | September 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2: Experimental
Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),
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Drug: drops intilation (Taponoto ® )
four drops, unique doses
|
|
3: Placebo Comparator
sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).
|
Drug: drops intilation (Placebo)
Placebo
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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®)
four drops, unique doses
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Hospital clinic of Barcelona ( Miguel Caballero / ENT specialist ) |
| Study ID Numbers: | CLO2008/4503 |
| Study First Received: | October 2, 2008 |
| Last Updated: | October 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00765635 |
| Health Authority: | Spain: Ministry of Health |
|
complete occlusion of the ear canal due to cerumen |
|
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness Otorhinolaryngologic Diseases |
Neurologic Manifestations Hearing Loss Ear Diseases Vertigo |
|
Nervous System Diseases Infection |
