Condition category
Ear, Nose and Throat
Date applied
27/01/2005
Date assigned
10/05/2005
Last edited
13/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian Williamson

ORCID ID

Contact details

Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 241071
igw@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Gentispray 001

Study information

Scientific title

A double blind, placebo controlled, multi-centre general practice study comparing the efficacy and tolerability of a spray with a drop presentation of Gentamicin and Hydrocortisone in patients with Otitis Externa.

Acronym

GOES

Study hypothesis

To compare the efficacy and tolerability of a spray versus a drop presentation of gentamicin and hydrocortisone for the treatment of otitis externa.

Ethics approval

Not provided at time of registration

Study design

Multicentre Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Otitis Externa

Intervention

Double blind, randomised, parallel group study comparing two groups of 60 patients on active treatment (spray or drop) and two groups of 15 placebo (spray or drop)

Please note that as of 13/08/2012 the record was updated to show that the trial was stopped in November 2007 due to lack of funding and patient recruitment issues.

Intervention type

Drug

Phase

Not Specified

Drug names

Gentamicin, hydrocortisone

Primary outcome measures

Total Efficacy Score (TSS) at day 10

Secondary outcome measures

TSS and the Global Impression Score at day 24, individual components of the TSS, and Patient Diary scores.

Overall trial start date

01/09/2004

Overall trial end date

31/08/2005

Reason abandoned

Lack of funding, Patient recruitment issues

Eligibility

Participant inclusion criteria

150 adult (over 18 yrs) patients presenting with bacterial otitis externa in general practice.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. A known or suspected perforation of the eardrum
2. Otitis externa secondary to otitis media
3. Chronic or fungal otitis externa, or a primary dermatological condition affecting the ear
4. Furuncles or infected mastoid cavities
5. A body temperature exceeding 38.3°C (101.0°F)
6. Abnormalities of the external auditory meatus, such as exostosis, tumours, etc.
7. Received any systemic antibiotic treatment for any indication in the last two weeks
8. Administered any topical ear preparation to the affected ear(s) in the last two weeks (including over the counter [OTC] preparations)
9. Hypersensitive to aminoglycoside antibiotics or corticosteroids or preservatives
10. Suffering from dizziness or vertigo
11. Is the patient diabetic or immunosuppressed
12. Taking systemic antibiotics
13. Administering any other topical ear preparation
14. Incapable of administering topical ear prepartions
15. In the investigator’s judgement, likely to be unreliable or uncooperative with the requirements and evaluation procedures outlined in this protocol
16. In the investigator’s judgement, showing clinical evidence of any unstable or clinically significant medical illness that may obscure the results of treatment

Recruitment start date

01/09/2004

Recruitment end date

31/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

Acorus Therapeutics Ltd (UK)

Sponsor details

High Crane Lodge
Hamsterley
Co. Durham
DL13 3QS
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Acorus Therapeutics Ltd (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

Publication citations

Additional files

Editorial Notes