Otodolor® eardrops/Otodolor® forte eardrops: a topical treatment of otitis externa
| ISRCTN | ISRCTN66288854 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66288854 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Open longitudinal multicentre non-interventional trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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. |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Otodolor® eardrops/Otodolor® forte eardrops |
| Primary outcome measure | 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 |
| Secondary outcome measures | Safety assessment (adverse drug reactions [ADRs]) |
| Overall study start date | 01/09/2008 |
| Overall study end date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 196 patients in the common general practice of 20 ENT doctors or paediatricians |
| Participant 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 |
| Participant exclusion criteria | 1. Patients under the age of 6 years 2. A known or suspected perforation of the eardrum |
| Recruitment start date | 01/09/2008 |
| Recruitment end date | 01/05/2009 |
Locations
Countries of recruitment
- Austria
Study participating centre
Specialist for ENT Surgery
Vienna
A-1060
Austria
A-1060
Austria
Sponsor information
Dr. Peithner KG nunmehr GmbH & Co (Austria)
Industry
Industry
c/o Dr Felix Kromer
Medical Services Department
Richard Strauss-Str. 13
Vienna
A-1232
Austria
| Phone | +43 (0)1 616 26 44 64 |
|---|---|
| med.service@peithner.at | |
| Website | http://www.peithner.at |
"ROR" |
https://ror.org/00wcjzh22 |
Funders
Funder type
Industry
Dr. Peithner KG nunmehr GmbH & Co (Austria)
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 |
