NCT05199441已完成4 期
Efficacy and Tolerability of Galeo® in Patients With Postprandial Distress Syndrome Subtype in Functional Dyspepsia: a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 6
- 主要终点
- gastrointestinal symptom total score at 4 weeks
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Galeo® on dyspepsia symptoms in patients with postprandial distress syndrome subtype in functional dyspepsia for 8 weeks.
详细描述
Galeo® already used an over-count drug for the improvement of dyspepsia symptoms. The investigators conduct a multi-center, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of Galeo® on dyspepsia symptoms in patients with postprandial distress syndrome subtype in functional dyspepsia for 8 weeks; the safety of the compound is also evaluated. The Investigators examine gastrointestinal symptom score (GIS) score, the Korean version of Nepean dyspepsia index (K-NDI), and OV efficacy at baseline and after 8 weeks of intervention. A total of 226 subjects were administered either 1,500 mg of Galeo® or a placebo each day for 8 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •postprandial distress syndrome according to Rome III criteria
- •Those who have at least 3 of the 10 symptoms of the GIS evaluation are moderate or more and have at least 1 of bloating, delayed digestion, belching, and nausea
- •Those with no organic lesions on the upper gastrointestinal endoscopy within 3 months prior to screening
排除标准
- •Those who have confirmed the following medical history or surgical history at the time of screening
- •Surgery that may affect gastrointestinal motility (eg, laparoscopic or laparotomy of the gastrointestinal tract) (except for appendectomy and hysterectomy due to simple appendicitis)
- •Diseases that can cause organic dyspepsia, such as irritable bowel syndrome, inflammatory bowel disease, gastroesophageal disease, and duodenal disease (gastric ulcer, esophagitis [from RE A], etc.) within 3 months before screening history of drug use
- •Malignant tumors of the digestive system (except in cases where there is no history of recurrence within 5 years or cases where a cure has been obtained)
- •Other malignant tumors other than the digestive system within 5 years (however, except for if there is no history of recurrence within 5 years or cured cases)
- •History of organic neurological or psychiatric disorders (major depressive disorder or anxiety disorder, etc.), alcoholism, substance abuse, and drug dependence (except nicotine and caffeine)
- •Those with the following diseases at the time of screening
- •Organic causes of gastroparesis (diabetic gastroparesis, etc.)
- •urinary tract disease or prostate disease
- •Biliary duct obstruction or biliary duct stones (eg, intrahepatic gallstones, extrahepatic gallstones)
- •uncontrolled diabetes mellitus (glycated hemoglobin > 8.0%)
- •Aspartate transaminase or alanine aminotransferase levels are more than 3 times the upper limit of normal, or total bilirubin levels are more than 3 times the upper limit of normal, or liver disease
- •Serum creatinine level is 1.5 times or more of the upper limit of normal, or renal disease
- •Other clinically significant diseases of the heart (blood pressure 160/100 mmHg or more), kidney, lung, blood, and endocrine system, and dysfunction that may affect efficacy and safety evaluation
- •Those who have administered the following drugs that may affect efficacy evaluation within 2 weeks before screening
- •emollient: artichoke extract, ursodeoxycholic acid, etc.
- •prokinetics: metoclopramide, itopride, etc.
- •inhibitors of gastric acid secretion: H2 receptor antagonist (proton pump inhibitor), gastric acid pump antagonist (acid pump antagonist)
- •gastric mucosal protective agent, antacid, digestive agent
- •fundus relaxants: sumatriptan, buspirone, etc.
- •cholinergic, anticholinergic and antispasmodic
- •psychotropic drugs: antipsychotic drugs, antidepressants, antimanic drugs, antianxiety drugs, hallucinogens, etc.
- •Nonsteroidal anti-inflammatory drugs (intermittent administration up to 1 week 2 days and cyclooxygenase-2 selective inhibitors are acceptable)
- •Antithrombotic agents (antiplatelet agents, anticoagulants)
- •systemic glucocorticoids
- •Erythromycin (However, in the case of eye drops, the administration is allowed) If the above drugs are administered, registration is possible after a wash-out period of at least 2 weeks, and drugs used for the purpose of pretreatment for upper gastrointestinal endoscopy (midazolam, propofol, simethicone), hyoscine butylbromide, cimetropium bromide, etc.) are allowed within 1 day.
- •Those who received Helicobacter pylori eradication treatment within 2 weeks before screening
- •Those who have administered or treated other clinical trial drugs or medical devices within 3 months prior to screening
- •Pregnant or lactating women
- •Women or men of childbearing potential who are unwilling to use an appropriate method of contraception* during this clinical trial
- •*hormonal contraceptives, implantation of intrauterine devices or intrauterine systems, vasectomy, tubal ligation, double-blocking contraception (using a cervical cap or diaphragm and a male condom simultaneously), etc.
- •If there are other diseases that may affect this clinical trial
- •Persons with hypersensitivity or allergy to clinical investigational drugs and similar drugs or to soybean oil, soybean, peanut
- •Persons judged unsuitable to participate in clinical trials by investigators
研究组 & 干预措施
Control group
Placebo Comparator
This group takes placebo for 4 weeks.
干预措施: Control group placebo (Drug)
Dihydroxydibutylether group
Experimental
This group takes dihydroxydibutylether for 4 weeks.
干预措施: Dihydroxydibutylether group (Drug)
结局指标
主要结局
gastrointestinal symptom total score at 4 weeks
时间窗: 4 weeks
Change in GIS total score at 4 weeks (Visit 4) compared to baseline (Visit 2). The minimum value was 0 and the maximum value was 40, and higher scores mean a worse outcome.
次要结局
- gastrointestinal symptom total score at 2 weeks(2 weeks)
- Seven-point Likert scale for overall treatment efficacy at 4 weeks(4 weeks)
- The Korean version of the Nepean Dyspepsia Index total score at 4 weeks(4 weeks)
- each gastrointestinal symptom score at 2, 4 weeks(2, 4 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital
研究点 (6)
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