Condition category
Ear, Nose and Throat
Date applied
23/09/2005
Date assigned
20/10/2006
Last edited
29/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Desmond Nunez

ORCID ID

Contact details

Academic Dept. of Otolaryngology
North Bristol NHS Trust
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NRR Pub ID N0234117609

Study information

Scientific title

Acronym

Study hypothesis

That there is no difference between plain steroid drops or combination steroid and antibiotic drops in the resolution of otitis externa.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Otitis Externa

Intervention

Aural toilet and Vista Metasone topical drops versus Aural toilet and topical Vista Metasone-N over a 2 week period

Intervention type

Drug

Phase

Not Applicable

Drug names

Plain steroid drops or combination steroid and antibiotic drops

Primary outcome measures

Subjects' visual analogue symptom scores for otitis externa pre and post treatment.

Secondary outcome measures

Observer' s visual analogue scores for signs of otitis externa pre and post treatment.

Overall trial start date

01/06/2003

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with otitis externa presenting to the otolaryngology emergency clinic of an acute urban teaching hospital.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

55

Participant exclusion criteria

1. Patients under the age of 18 years
2. Diabetics
3. Immunocompromise
4. Evidence of concurrent middle ear disease
5. Non-English speakers
6. Mental impairment
7. Allergy to the medicine
8. Previous treatment with the trial medication
9. Patients declining to participate

Recruitment start date

01/06/2003

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Dept. of Otolaryngology
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

Research & Development Support Unit
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Internal: Department of Otolaryngology, North Bristol NHS Trust (own account) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18560873

Publication citations

  1. Results

    Abelardo E, Pope L, Rajkumar K, Greenwood R, Nunez DA, A double-blind randomised clinical trial of the treatment of otitis externa using topical steroid alone versus topical steroid-antibiotic therapy., Eur Arch Otorhinolaryngol, 2009, 266, 1, 41-45, doi: 10.1007/s00405-008-0712-y.

Additional files

Editorial Notes