Status:
COMPLETED
Efficacy of Galeo® in Patients With Postprandial Distress Syndrome Subtype in Functional Dyspepsia
Lead Sponsor:
Pusan National University Yangsan Hospital
Conditions:
Dyspepsia
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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 fun...
Detailed Description
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 invest...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT05199441
Start Date
February 25 2022
End Date
July 7 2023
Last Update
January 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea, 50612