2022-501349-64-00招募中2 期
A Phase 2, Double-Blind, 12 Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules in Pediatric Subjects Aged 2 to 11 Years With Symptomatic Nonerosive Gastroesophageal Reflux Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- The percentage of days without hurting or burning in the stomach, chest or throat over the 12 weeks of treatment.
研究概览
简要总结
To assess the safety and effectiveness of treatment with QD oral administration of dexlansoprazole delayed release capsules (15,30, and 60 mg) in pediatric subjects aged 2 to 11 years with symptomatic nonerosive GERD
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment Period
- 盲法
- Double (Investigator, Subject, Carer, Analyst, Monitor)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Medical history of GERD symptoms for at least 3 months prior to Screening.
- •Reported symptoms of hurting or burning in the stomach, chest, or throat on at least 3 out of any 7 consecutive days as recorded in the eDiary during screening.
- •No evidence of erosive esophagitis according to the LA Classification of Esophagitis and, in the investigator's clinical judgment, the symptoms are suggestive of acid-related disease. A 24-hour pH-metry (with or without impedance) may be performed during Screening or within 6 months prior to Screening for similar symptoms as those identified during Screening if, in the investigator's judgment, this procedure would aid in the determination of whether the subject's symptoms are acid related.
排除标准
- •Erosive esophagitis.
- •History of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or antacid or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole).
- •Evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergic skin rash that suggests any uncontrolled, clinically significant underlying disease or condition (other than the disease being studied), which may impact the ability of the subject to participate or potentially confound the study results.
- •Any findings in medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.
- •Known history of Barrett's esophagus with dysplastic changes in the esophagus.
- •History of the following: eosinophilic esophagitis (EoE) or histologic findings suggestive of EoE (>15 eosinophils per high-powered field [HPF]); a history of celiac disease or tests positive for tissue transglutaminase (tTG) antibody or confirmed disease by histology; inflammatory bowel disease; or irritable bowel syndrome.
- •Active gastric or duodenal ulcers within 4 weeks prior to Day -
- •Subjects who are required to take prescription or nonprescription medications as listed in Excluded Medications and Treatment Section of the protocol (Section 7.3).
结局指标
主要结局
The percentage of days without hurting or burning in the stomach, chest or throat over the 12 weeks of treatment.
The percentage of days without hurting or burning in the stomach, chest or throat over the 12 weeks of treatment.
次要结局
- Percentage of days without hurting or burning in the stomach, chest or throat in children aged 9 to 11 years over the 12 weeks of treatment.
- Percentage of days without hurting or burning in the stomach, chest or throat in children aged 2 to 8 years over the 12 weeks of treatment.
- Percentage of days without vomiting over the 12 weeks of treatment.
- Percentage of days food did not come up from stomach to mouth over the 12 weeks of treatment.
- Percentage of days without trouble eating over the 12 weeks of treatment.
- Comparison of the difference of the mean percentage of days without hurting or burning in the stomach, chest, or throat over the 12 weeks of treatment between the high dose and the low dose within each weight strata.
研究者
Even Huang
Scientific
Takeda Development Center Americas Inc.
研究点 (3)
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