Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Prospective, Placebo Controlled, Randomized, double-blinded Parallel-Group Comparison for Superiority

Phase 3

• Conditions: Acute Otitis Media (AOM)H65.0 und H66.0Upper respiratory tract infection; H65.0; H66.0; Acute serous otitis media; Acute suppurative otitis media

• Registration Number: DRKS00004569
• Lead Sponsor: Weber & Weber GmbH & Co. KGBiologische Arzneimittel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-24
• Study Completion: 2015-06-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

1. Children aged 12 to 59 months
2. Children with at least 3 episodes of acute otitis media (AOM) during the last 12 months Prior to study inclusion as documented in their medical records.
3. Written informed consent.

Exclusion Criteria

1. Ongoing acute otitis media or URI (subjects may be included after resolution)
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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the number of AOM (Acute Otitis Media) episodes within 12 months after enrolment per patient. The mean difference in the number of AOMs before and during the study of both parallel groups will be used for testing the hypothesis of superiority of Otovowen.

Secondary Outcome Measures

Name	Time	Method
- Number of doctor visits due to AOM (determined continuously during observational period)<br>- Number of doctor visits due to URI (determined continuously during observational period)<br>- Number of URI treated with antibiotics (determined continuously during observational period)<br>- Number of days with URI (determined continuously during observational period) <br>- Subjective evaluation of efficacy by parent (determined at the end of observational period)<br>- Subjective evaluation of tolerability by parent (determined at the end of observational period)<br>- Adverse events (determined continuously during observational period)<br>- Use of antipyretic, analgesic and antibiotic medication (determined continuously during observational period)<br>- Number of absent days from daycare (patient) / work (parent), (determined continuously during observational period)<br>