Otodolor® eardrops/Otodolor® forte eardrops: a topical treatment of otitis externa
| ISRCTN | ISRCTN66288854 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66288854 |
| Protocol serial number | N/A |
| Sponsor | Dr. Peithner KG nunmehr GmbH & Co (Austria) |
| Funder | Dr. Peithner KG nunmehr GmbH & Co (Austria) |
- Submission date
- 08/10/2009
- Registration date
- 22/10/2009
- Last edited
- 03/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Prof Dr Andreas Temmel
Scientific
Scientific
Specialist for ENT Surgery
KH der Barmherzigen Schwestern
Stumpergasse 13
Vienna
A-1060
Austria
Study information
| Primary study design | Observational |
|---|---|
| Study design | Open longitudinal multicentre non-interventional trial |
| Secondary study design | Multi-centre |
| Study type | Participant information sheet |
| Scientific title | Safety and efficacy of the homeopathic remedies Otodolor® eardrops/Otodolor® forte eardrops for topical treatment of otitis externa: a non-interventional trial |
| Study acronym | OTO1 |
| Study objectives | Systematic and prospective data collection on safety and efficacy of homeopathic remedies (Otodolor® eardrops/Otodolor® forte eardrops) for topical treatment of otitis externa in children and adults in the common general practice of ear, nose and throat (ENT) doctors or paediatricians. This trial will assess the following: 1. The reduction of subjective and objective complaints like redness, swelling, eczematous affections, secretion, ear pain and itching 2. The reduction of other otitis externa medications under therapy 3. Safety data (adverse drug reactions [ADRs]) |
| Ethics approval(s) | Submission of a non-interventional study to Regulatory Board/Ethics Committee is not necessary in Austria until after June 2010. |
| Health condition(s) or problem(s) studied | Otitis externa |
| Intervention | Otodolor® eardrops (every 2 - 4 hours, 3 - 5 drops/ear) or Otodolor® forte eardrops (every 2 - 4 hours, 3 - 5 drops/ear) for topical treatment of otitis externa over a 2-week period. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Otodolor® eardrops/Otodolor® forte eardrops |
| Primary outcome measure(s) |
1. The reduction of subjective and objective complaints like redness, swelling, eczematous affections, secretion, ear pain and itching |
| Key secondary outcome measure(s) |
Safety assessment (adverse drug reactions [ADRs]) |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 196 |
| Key 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 |
| Key exclusion criteria | 1. Patients under the age of 6 years 2. A known or suspected perforation of the eardrum |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Austria
Study participating centre
Specialist for ENT Surgery
Vienna
A-1060
Austria
A-1060
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
