Condition category
Ear, Nose and Throat
Date applied
08/10/2009
Date assigned
22/10/2009
Last edited
03/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dr Andreas Temmel

ORCID ID

Contact details

Specialist for ENT Surgery
KH der Barmherzigen Schwestern
Stumpergasse 13
Vienna
A-1060
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Safety and efficacy of the homeopathic remedies Otodolor® eardrops/Otodolor® forte eardrops for topical treatment of otitis externa: a non-interventional trial

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

Submission of a non-interventional study to Regulatory Board/Ethics Committee is not necessary in Austria until after June 2010.

Study design

Open longitudinal multicentre non-interventional trial

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Otodolor® eardrops/Otodolor® forte eardrops

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Other

Gender

Both

Target number of participants

196 patients in the common general practice of 20 ENT doctors or paediatricians

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

Trial participating centre

Specialist for ENT Surgery
Vienna
A-1060
Austria

Sponsor information

Organisation

Dr. Peithner KG nunmehr GmbH & Co (Austria)

Sponsor details

c/o Dr Felix Kromer
Medical Services Department
Richard Strauss-Str. 13
Vienna
A-1232
Austria
+43 (0)1 616 26 44 64
med.service@peithner.at

Sponsor type

Industry

Website

http://www.peithner.at

Funders

Funder type

Industry

Funder name

Dr. Peithner KG nunmehr GmbH & Co (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes