jRCT2031240419进行中（未招募）不适用
TK-042 Phase III Clinical Study A Double-blind, Parallel-group Phase III study in pediatric patients with seasonal allergic rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 310
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 7age old over 至 12age old not（—）
- 性别
- All
入选标准
- •>= 7 to < 12 years of age.
- •Have positive (class >= 2) specific IgE antibodies test (e.g., CAP-RAST, AlaSTAT 3g, etc.) for antigens of cedar pollen.
排除标准
- •Have concomitant nasal disorders (e.g., nasal polyps, nasal septum deviation, hypertrophic rhinitis, etc.) or infectious diseases (e.g., upper respiratory tract inflammation, sinusitis, infectious rhinitis, eye Infections, etc.) to a degree that would interfere with the efficacy valuation.
- •Have non-allergic rhinitis (e.g., vasomotor, infectious, drug-induced, etc.) or history of non-allergic rhinitis .
- •Have undergone coagulation (e.g., laser) or ablative surgery for the treatment of nasal symptoms within 1 year prior to screening.
- •Have uncontrolled mild and moderate bronchial asthma (patients with conditions that require the use of injectable, oral, or inhaled steroid preparations), or severe bronchial asthma.
- •Have a history of hypersensitivity to antihistamines, including this drug , or any ingredient of investigational drugs.
- •Have severe hepatobiliary disorders.
- •Have severe renal or urinary disorders.
结局指标
主要结局
-
Change from baseline in total nose symptom score
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
1 期
Perioperative treatment of locally advanced resectable gastric or GEJ adenocarcinomaGastric and gastroesophageal junction (GEJ) adenocarcinomaMedDRA version: 20.0Level: PTClassification code: 10001150Term: Adenocarcinoma gastric Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10066354Term: Adenocarcinoma of the gastroesophageal junction Class: 10029104CTIS2023-509595-42-00Merck Sharp & Dohme LLC1,122
进行中（未招募）
不适用
sitagliptin +simvastatin coadministration safety studyType 2 diabetes mellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-001868-29-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.750
进行中（未招募）
不适用
sitagliptin +simvastatin coadministration safety studyEUCTR2012-001868-29-LTMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.750
进行中（未招募）
1 期
sitagliptin +simvastatin coadministration safety studyType 2 diabetes mellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-001868-29-CZMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.750
进行中（未招募）
不适用
sitagliptin +simvastatin coadministration safety studyEUCTR2012-001868-29-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.750