Otitis Externa Ear, Nose and Throat Otitis externa
Conditions
Interventions
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 t
Sponsors
Acorus Therapeutics Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 150 adult (over 18 yrs) patients presenting with bacterial otitis externa in general practice.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Efficacy Score (TSS) at day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| TSS and the Global Impression Score at day 24, individual components of the TSS, and Patient Diary scores. | — |
Countries
United Kingdom
Outcome results
None listed