- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05199441
Efficacy of Galeo® in Patients With Postprandial Distress Syndrome Subtype in Functional Dyspepsia
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Gyeungsangnam-do
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Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
- Pusan National University Yangsan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dihydroxydibutylether group
This group takes dihydroxydibutylether for 8 weeks.
|
This group takes 1.500 mg/day of dihydroxydibutylether for 8 weeks.
Other Names:
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Placebo Comparator: Control group
This group takes placebo for 8 weeks.
|
This group takes 1,500 mg/day of placebo for 8 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gastrointestinal symptom total score at 4 weeks
Time Frame: 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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Korean version of the Nepean Dyspepsia Index total score at 4 weeks
Time Frame: 4 weeks
|
Change in the Korean version of the Nepean Dyspepsia Index total score at 4 weeks (Visit 4) compared to baseline (Visit 2).
The minimum value was 0 and the maximum value was 195, and higher scores mean a worse outcome.
|
4 weeks
|
gastrointestinal symptom total score at 2 weeks
Time Frame: 2 weeks
|
Change in GIS total score at 2 weeks (Visit 3) compared to baseline (Visit 2).
The minimum value was 0 and the maximum value was 40, and higher scores mean a worse outcome.
|
2 weeks
|
Seven-point Likert scale for overall treatment efficacy at 4 weeks
Time Frame: 4 weeks
|
Seven-point Likert scale for overall treatment efficacy evaluated by the subject at 4 weeks (Visit 4) after administration of the clinical trial drug.
The minimum value was -3 and the maximum value was +3, and higher scores mean a better outcome.
|
4 weeks
|
each gastrointestinal symptom score at 2, 4 weeks
Time Frame: 2, 4 weeks
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Score change for each GIS symptom at 2 and 4 weeks (Visit 3, Visit 4) compared to the baseline (Visit 2).
For each gastrointestinal symptom, the minimum value was 0 and the maximum value was 4, and higher scores mean a worse outcome.
|
2, 4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-2021-034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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