Does a herbal-based medicine compared with a placebo (dummy drug) reduce the number of episodes with middle ear infection?

• Conditions: Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]; recurrent acute otitis media; MedDRA version: 16.1Level: PTClassification code 10033078Term: Otitis mediaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 16.1Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2012-000341-13-DE
• Lead Sponsor: Weber & Weber GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-25
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>2. To investigate pharmacoeconomic aspects of Otovowen <br>3. To investigate whether Otovowen is well tolerated and effective as assessed by parents/legal representative(s).<br>4. To assess safety of Otovowen treatment<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Total number of AOM per treatment group<br>- Number of visits due to AOM<br>- Number of AOM treated with antibiotics<br>- Number of visits due to URI<br>- Number of URI treated with antibiotics<br>- Number of days with URI <br>- Subjective evaluation of efficacy by parent<br>- Subjective evaluation of tolerability by parent<br>- Adverse events<br>- Use of antipyretic, analgesic and antibiotic medication<br>- 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