NCT02601235已完成3 期
Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.
EMS1 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2018年1月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Relief of Nasal Congestion
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.
详细描述
Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 10-17 years old with clinical symptoms of inflammatory of allergic nasal congestion in at least one nostril due to rhinitis or rhinopharyngitis (cold or flu);
- •Signed Consent;
- •Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;
- •Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;
- •Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).
排除标准
- •Participation in clinical trial in the year prior to this study;
- •Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;
- •Infectious bacterial-disease (clinically diagnosed);
- •Participants treated with antibiotic or possible antibiotic use due to another medical condition;
- •Use of intranasal corticosteroids (7 days prior to the study) or systemic (15 days prior to the study), regarding the plasma half-life of the drug;
- •Use of decongestants or antihistamine (intranasal or systemic) in the 03 days prior to the study;
- •Use of inhaled drugs (except nasal moisturizers such as saline solution) or treatment with immunosuppressants in the week before the study;
- •Participants with septum deviation grade II and III, nasal polyps, severe turbinate hypertrophy, adenoid hypertrophy, or other determining factors for nasal obstruction;
- •History of hyperthyroidism or hypertension;
- •History of hypersensitivity to the components of the study drugs;
- •History of transphenoidal hypophysectomy or oronasal surgery with exposure of the dura-mater;
- •Exclusive mouth-breathers patients;
- •Participants in chronic drug treatment for allergies (eg vaccines for allergy, cromolyn);
- •History of alcohol and / or drug abuse 3 months prior to the study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •PAny clinical, laboratory that, in the judgment of the investigator, may interfere with the safety of research participants.
研究组 & 干预措施
Naridrin
Experimental
Naridrin: 2 drops in each nostril once daily as prescription
干预措施: Naridrin (Drug)
0.05 % Oxymetazoline Hydrochloride
Active Comparator
2 pumps in each nostril every 12 hours
干预措施: Afrin (Drug)
结局指标
主要结局
Relief of Nasal Congestion
时间窗: 2 days
Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion)
次要结局
- Adverse Events(2 days)
研究者
研究点 (1)
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