A Phase III Multicentre, Parallel-group, Randomized, Placebo-controlled, Double-blind Clinical Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Chronic Urticaria.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 239
- 主要终点
- Number of Participants Who Discontinued Study Drug Due to an AE
研究概览
简要总结
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic urticaria [rash (erythema, wheal) for more than 1 month without any known cause]
- •Out-patient
排除标准
- •Stimulation-induced urticaria [physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)]
- •Hypersensitivity to antihistamines or ingredients of a study drug
研究组 & 干预措施
Desloratadine 5 mg
Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
干预措施: Desloratadine (Drug)
Desloratadine 5 mg
Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
干预措施: Placebo (Drug)
Desloratadine 10 mg
Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
干预措施: Desloratadine (Drug)
Placebo
Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Discontinued Study Drug Due to an AE
时间窗: Up to 2 weeks
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2
时间窗: Baseline Visit and Week 2 Visit
The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.
Number of Participants Who Experienced at Least One Adverse Event (AE)
时间窗: Up to 4 weeks (Up to 2 weeks after last dose of study drug)
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.
次要结局
- Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit)
- Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit)
- Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit)
- Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1(Baseline Visit and Day 3 Visit, Week 1 Visit)
- Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit)
- Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit)
- Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit)
- Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2(Baseline Visit and Week 1 Visit, Week 2 Visit)