A Randomized, Double Blind, Placebo Controlled, Parallel-Group, Multicentre, Phase III Study to Compare the Efficacy and Safety of Acotiamide 100 mg Tablets with Placebo in Patients with Functional Dyspepsia.

PIN Limited0 个研究点目标入组 222 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Diagnosed as Functional Dyspepsia â?? Postprandial Distress Syndrome as defined by the Rome III classification
•2.Patients with at least one of the following two symptoms for at least 6 months
•Postprandial fullness
•Early satiety
•Patients with two or more of the following symptoms at a moderate or severe level within the previous 3 months (At least one symptom of postprandial fullness, upper abdominal bloating or early satiety should be included):
•Upper abdominal pain
•Upper abdominal discomfort
•Postprandial fullness
•Upper abdominal bloating
•Early satiety
•Excessive belching
•3.Patients with coexisting epigastric pain syndrome symptoms (epigastric pain, epigastric burning) may be included, but the symptom causing the most distress at the time of screening should be one of the following meal-related symptoms: postprandial fullness, upper abdominal bloating or early satiation

•1.Subjects with any structural disease of esophagus, stomach or duodenum that is likely to explain the symptoms.
•2.History of heartburn within 12 weeks prior to screening and during the 7 days of baseline period
•3.Any gastrointestinal co-morbidity like irritable bowel syndrome which may confound the evaluation of symptoms
•4.Presence of any severe or malignant disease
•5.Patients with renal or hepatic dysfunction

发起方

PIN Limited