A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety andEffectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent subjects Aged 12 to17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

TAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD0 个研究点目标入组 104 人开始时间: 2012年10月17日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•The subjects must be aged between 12 and 17 years (inclusive) and have a history of symptoms of gastroesophageal reflux disease (GERD) at least 3 months prior to screening, based on assessments of the investigator. To be enrolled in the study, patients must have heartburn for at least 3 days out of 7 during the screening period, bringing in the daily electronic diary.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•patients with erosive esophagitis. Subjects with a history of hypersensitivity or allergic to dexlansoprazolo, any of its components, antacids or any proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole and esomeprazole). Subjects who show evidence of cardiovascular, pulmonary, central nervous system, liver, hematopoietic, renal, metabolic, endocrine or gastrointestinal, or with severe allergies, asthma or skin rashes suggestive of allergic origin of diseases or conditions are not controlled and significant (different from the disease under study) that could interfere with the ability to participate in the subject or potentially confuse the results of the study, or clinically important findings arising from the results of physical examination or laboratory analysis, in the opinion of the investigator. Persons who must take prescription drugs or over the counter drugs and treatments listed in the section except the protocol (Section 7.3).

发起方

TAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD