NCT00621959已完成4 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine 5 mg Once Daily Given for 2 Weeks in Subjects 18 yr of Age and Older With Seasonal Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 596
- 主要终点
- Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
研究概览
简要总结
The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a history of SAR symptoms
- •A positive skin prick test at least one grass allergen
- •Moderate - severe SAR symptoms at baseline
- •Women of childbearing potential must use a medically acceptable form of contraception
- •80% compliance on run in study medication and 80% compliance on completing the diary
排除标准
- •The presence of any clinically significant comorbid disease which may interfere with the study assessments
- •The presence of renal disease
- •Pregnant or breastfeeding
- •Subject is currently participating in another clinical trial
- •Known hypersensitivity to piperazines or any of the excipients
- •Intake of medications prohibited before the start of the trial
- •Subjects who started or changed the dose of immunotherapy
- •Rhinitis medicamentosa
- •Subjects with a recent history (within the last 2 years) of drug or alcohol abuse.
研究组 & 干预措施
Placebo
Placebo Comparator
Matched placebo tablets once daily
干预措施: placebo (Drug)
LCTZ
Experimental
5 mg levocetirizine dihydrochloride tablet
干预措施: levocetirizine dihydrochloride (Drug)
结局指标
主要结局
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
时间窗: Over the total treatment period (14 days)
Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.
次要结局
- Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score(Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days))
研究者
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