Otodolor® eardrops/Otodolor® forte eardrops: a topical treatment of otitis externa

Completed

• Conditions: Otitis externa; Ear, Nose and Throat

• Registration Number: ISRCTN66288854
• Lead Sponsor: Dr. Peithner KG nunmehr GmbH & Co (Austria)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

1. Patients with acute or chronic otitis externa presenting to ENT doctors or paediatricians
2. Children aged 6 years onwards and adults (either sex) for Otodolor® eardrops
3. Children aged 12 years onwards and adults (either sex) for Otodolor® forte eardrops

Exclusion Criteria

1. Patients under the age of 6 years
2. A known or suspected perforation of the eardrum

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The reduction of subjective and objective complaints like redness, swelling, eczematous affections, secretion, ear pain and itching <br>2. The reduction of other otitis externa medications under therapy

Secondary Outcome Measures

Name	Time	Method
Safety assessment (adverse drug reactions [ADRs])