recurrent acute otitis media MedDRA version: 16.1 Level: PT Classification code 10033078 Term: Otitis media System Organ Class: 10021881 - Infections and infestations MedDRA version: 16.1 Level: PT Classification code 10033079 Term: Otitis media acute System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Otovowen
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: ECHINACEA PURPUREA
CAS Number: 8001002-85-5
Other descriptive name: ECHINACEA PURPUREA
Concentration unit: % (V/V) p
Sponsors
Weber & Weber GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 12 to 59 months 2. Children with at least 3 episodes of acute otitis media (AOM) since October 1st, 2012 as documented in their medical records. Diagnosis criteria for AOM see study protocol. 3. Written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: 296 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Ongoing acute otitis media or URI 2. Current prophylaxis/treatment for URI or AOM 3. Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties 4. Use of tympanostomy tubes 5. Chronic tympanic membrane perforation (TMP) 6. Palatine cleft 7. Parents/legal representative(s) of children unable to follow study procedures, who have no internet access and are not willing to use an online diary on a weekly basis 8. History of hypersensitivity to the investigational drug or to its ingredients. 9. Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator’s opinion, would contraindicate study participation or compliance with protocol mandated procedures. 10. Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the superiority of Otovowen to placebo in the prevention of acute otitis media;Secondary Objective: 1. To investigate that Otovowen is superior to placebo in reducing URI and URI-related doctor visits. 2. To investigate pharmacoeconomic aspects of Otovowen 3. To investigate whether Otovowen is well tolerated and effective as assessed by parents/legal representative(s). 4. To assess safety of Otovowen treatment ;Primary end point(s): To determine the number of AOM episodes diagnosed by a physician within 6 months after enrolment per patient. The difference in the mean number of AOMs per patient comparing both parallel groups will be used for testing the hypothesis of superiority of Otovowen.;Timepoint(s) of evaluation of this end point: At the end of the individual 6 months observational period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Total number of AOM per treatment group - Number of visits due to AOM - Number of AOM treated with antibiotics - Number of visits due to URI - Number of URI treated with antibiotics - Number of days with URI - Subjective evaluation of efficacy by parent - Subjective evaluation of tolerability by parent - Adverse events - Use of antipyretic, analgesic and antibiotic medication - Number of absent days from daycare (patient) / work (parent);Timepoint(s) of evaluation of this end point: At the end of the individual 6 months observational period | — |
Countries
Germany
Contacts
Public ContactMed. Wiss. Dr. rer. nat. U. Danesch
Weber & Weber GmbH & Co. KG
Outcome results
None listed