Gentamicin hydrocortisone formulations in Otitis Externa Study (GOES)
| ISRCTN | ISRCTN38568489 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38568489 |
| Protocol serial number | Gentispray 001 |
| Sponsor | Acorus Therapeutics Ltd (UK) |
| Funder | Acorus Therapeutics Ltd (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre Randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gentamicin, hydrocortisone |
| Primary outcome measure(s) |
Total Efficacy Score (TSS) at day 10 |
| Key secondary outcome measure(s) |
TSS and the Global Impression Score at day 24, individual components of the TSS, and Patient Diary scores. |
| 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 | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
