A Phase III, Multicenter, Open-Label Long-Term Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Eczema/Dermatitis and Dermal Pruritus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2
研究概览
简要总结
This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study is that the sum of the daytime and nighttime pruritus/itch scores for both the eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week 2 compared to Baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema, neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is appropriate)
- •Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)
排除标准
- •Hypersensitivity to antihistamines or ingredients of a study drug
研究组 & 干预措施
Desloratadine: Eczema/Dermatitis
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient antipruritic efficacy and there is no safety concern.
干预措施: Desloratadine 5 mg (Drug)
Desloratadine: Dermal Puritus
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
干预措施: Desloratadine 5 mg (Drug)
结局指标
主要结局
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the 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 sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated.
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
时间窗: Up to 14 weeks (Up to 2 weeks after last dose 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.
Percentage of Participants Who Discontinued Study Drug Due to an AE
时间窗: Up to 12 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.
次要结局
- Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit)
- Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit)
- Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12(Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit)