A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
2017年1月18日 更新者：ALK-Abelló A/S
A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet (SCH 39641/MK-3641) Treatment in Ragweed Allergic Adults (Phase 3, Protocol No.P05751)
This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma.
The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.
研究概览
研究类型
介入性
注册 (实际的)
914
阶段
- 第三阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma
- Must have a positive skin prick test response to Ambrosia artemisiifolia
- Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value
- Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor
- Females of child-bearing potential must agree to use medically accepted methods of contraception
Exclusion Criteria:
- Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months
- Received an immunosuppressive treatment within 3 months
- History of anaphylaxis with cardio-respiratory symptoms.
- History of chronic urticaria or angioedema
- Current severe atopic dermatitis
- Female subject who is breastfeeding, pregnant, or intending to become pregnant
- Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years
- History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine
- Unable to or will not comply with the use of self-injectable epinephrine
- Participating in any other clinical trial
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：SCH 39641 12 Amb a 1-U
12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily.
|
Rapidly dissolving tablet sublingually once daily
其他名称：
|
|
安慰剂比较：Placebo
Matching placebo tablet, sublingual, once daily.
|
Rapidly dissolving tablet sublingually once daily
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs)
大体时间：Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded.
An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.
|
Up to Day 35
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Reporting Oral Pruritus.
大体时间：Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
|
Number of Participants Reporting Ear Pruritus
大体时间：Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
|
Number of Participants Reporting Throat Irritation
大体时间：Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
|
Number of Participants Reporting Mouth Oedema
大体时间：Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
|
Number of Participants Reporting Eye Pruritus
大体时间：Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
|
Number of Participants Reporting Nasal Passage Irritation
大体时间：Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
|
Number of Participants Reporting Skin Pruritus
大体时间：Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
|
Number of Participants Who Discontinued Due to Treatment-emergent AEs
大体时间：Up to Day 28
|
Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded.
An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.
|
Up to Day 28
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年11月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2011年10月21日
首先提交符合 QC 标准的
2011年11月9日
首次发布 (估计)
2011年11月10日
研究记录更新
最后更新发布 (实际的)
2017年3月3日
上次提交的符合 QC 标准的更新
2017年1月18日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.