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

Weber & Weber GmbH & Co. KG0 个研究点开始时间: 2012年4月25日最近更新: 2015年12月22日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Weber & Weber GmbH & Co. KG