Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,003
- 主要终点
- Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies
研究概览
简要总结
The purpose of this study is to collect information on unexpected adverse reactions (ADRs), how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin (loratadine) when used in children. Patients will be observed while they are taking Claritin, and ADRs and symptom scores will be recorded. At the end of treatment, improvement in symptoms will be recorded.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 3 to 15 years who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous)
排除标准
- 未提供
研究组 & 干预措施
Group 1
Pediatric patients who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous)
干预措施: loratadine (Drug)
结局指标
主要结局
Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies
时间窗: During and at the end of the observation period
Allergic rhinitis: nasal symptom scores (paroxysmal sneeze, nasal discharge, nasal congestion, and intranasal itching)
时间窗: Before the start of treatment, during the observation period, and at the end of the observation period
Urticaria, eczema, dermatitis, pruritus cutaneous: severity score of itching
时间窗: Before the start of treatment, during the observation period, and at the end of the observation period
次要结局
- Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable(At the end of the observation period)
- Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable(At the end of the observation period)