DRKS00004569已完成3 期
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 - OTV.PRE.01
Weber & Weber GmbH & Co. KGBiologische Arzneimittel0 个研究点目标入组 311 人开始时间: 2014年1月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 311
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 Months 至 59 Months（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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Does a herbal-based medicine compared with a placebo (dummy drug) reduce the number of episodes with middle ear infection?recurrent acute otitis mediaMedDRA version: 16.1Level: PTClassification code 10033078Term: Otitis mediaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 16.1Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-000341-13-DEWeber & Weber GmbH & Co. KG
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