Efficacy of Galeo® in Patients With Postprandial Distress Syndrome Subtype in Functional Dyspepsia

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.

Inclusion criteria

• 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

Exclusion criteria

• 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.)
• glaucoma
• 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