Gentamicin hydrocortisone formulations in Otitis Externa Study (GOES)
| ISRCTN | ISRCTN38568489 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38568489 |
| Secondary identifying numbers | Gentispray 001 |
- Submission date
- 27/01/2005
- Registration date
- 10/05/2005
- Last edited
- 13/08/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian Williamson
Scientific
Scientific
Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)2380 241071 |
|---|---|
| igw@soton.ac.uk |
Study information
| Study design | Multicentre Randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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. |
| Study acronym | GOES |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gentamicin, hydrocortisone |
| Primary outcome measure | 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 study start date | 01/09/2004 |
| Completion date | 31/08/2005 |
| Reason abandoned (if study stopped) | Lack of funding, Patient recruitment issues |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 150 adult (over 18 yrs) patients presenting with bacterial otitis externa in general practice. |
| Key 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 investigators judgement, likely to be unreliable or uncooperative with the requirements and evaluation procedures outlined in this protocol 16. In the investigators judgement, showing clinical evidence of any unstable or clinically significant medical illness that may obscure the results of treatment |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/08/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Sponsor information
Acorus Therapeutics Ltd (UK)
Industry
Industry
High Crane Lodge
Hamsterley
Co. Durham
DL13 3QS
United Kingdom
Funders
Funder type
Industry
Acorus Therapeutics Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
