Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study whether a herbal-based medication is superior to placebo for prevention of acute otitis media in pre-school children with upper respiratory tract infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen

Criteria

Inclusion Criteria:

• Children with at least 3 episodes of acute otitis media (AOM) within 12 months prior to study inclusion as documented in their medical records. Diagnosis criteria for AOM see study protocol

• parental written consent

Exclusion Criteria:

• Ongoing acute otitis media or URI

• Current prophylaxis/treatment for URI or AOM

• Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties

• Use of tympanostomy tubes

• Chronic tympanic membrane perforation (TMP)

• Palatine cleft

• 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

• History of hypersensitivity to the investigational drug or to its ingredients.

• 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.

• 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.