NCT04260555Unknown3 期
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Bronchitis Severity Score(BSS)
研究概览
简要总结
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis
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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender, 19 years ≤ age ≤ 80 years
- •Bronchitis Severity Score* ≥ 5point at Visit 2 (Randomized Visit)
- •Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
- •Those who can comply with the requirements of clinical trials
- •Written consent voluntarily to participate in this clinical trial
排除标准
- •Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- •Patients with systemic infections requiring systemic antibiotic therapy
- •patient with hemostatic disorder
研究组 & 干预措施
TEST
Experimental
tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml
干预措施: DW1601 (Drug)
Reference 1
Active Comparator
tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml
干预措施: DW16011 (Drug)
Reference 2
Active Comparator
tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml
干预措施: DW16012 (Drug)
结局指标
主要结局
Bronchitis Severity Score(BSS)
时间窗: Day 4
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for EmesisPostoperative Nausea and Vomiting (PONV)EUCTR2005-005855-16-BEGlaxoSmithKline Research and Development Ltd462
进行中（未招募）
1 期
A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for EmesisEUCTR2005-005855-16-HUGlaxoSmithKline Research and Development Ltd
进行中（未招募）
不适用
A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for EmesisPostoperative Nausea and Vomiting (PONV)EUCTR2005-005855-16-DEGlaxoSmithKline Research and Development Ltd462
进行中（未招募）
不适用
A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for EmesisPostoperative Nausea and Vomiting (PONV)EUCTR2005-005855-16-CZGlaxoSmithKline Research and Development Ltd462
招募中
1 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis with Randomized Withdrawal and RetreatmentModerate to Severe Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code: 10071117Term: Plaque psoriasis Class: 10040785CTIS2023-505120-59-00Janssen - Cilag International600