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Completed

NCT Number: NCT00765635

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.

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Key information

Conditions

Ear Infection Ear Diseases Hearing Disorders Hearing Loss Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otitis Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic

Barcelona, barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of ear cerumen

Exclusion criteria

  • Infection

Treatment and study plan

drops intilation (Taponoto ® )

Drug

four drops, unique doses

drops intilation (Otocerum®)

Drug

four drops, unique doses

drops intilation (Placebo)

Drug

Placebo

Primary outcomes

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

    Time frame: 2008

Secondary outcomes

  1. adverse effects

    Time frame: 2008

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
First posted
Oct 3, 2008
Registry last updated
Oct 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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