DyspepsiaPhase 4NCT05199441
Efficacy of Galeo® in Patients With Postprandial Distress Syndrome Subtype in Functional Dyspepsia
A Phase 4 study testing Dihydroxydibutylether group in people with Dyspepsia, run by Pusan National University Yangsan Hospital at 6 sites in South Korea.
Trial 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 functional dyspepsia for 8 weeks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Dihydroxydibutylether group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 25 Feb 2022to 7 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 35Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Hallym University Sacred Heart Hospital
Anyang
Dong-A University Hospital
Busan
Chungnam National University Hospital
Daejeon
Korea University Guro Hospital
Seoul
Koreal University Anam Hospital
Seoul
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
Official title: 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
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.
Read the 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 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.
- Conditions
- Dyspepsia
- Being tested
- Dihydroxydibutylether group, Control group placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroxydibutylether groupDrug
Also called Galeo® group
This group takes 1.500 mg/day of dihydroxydibutylether for 4 weeks. Participants were instructed to take one capsule orally three times daily, 30 minutes before each meal.
Control group placeboDrug
Also called Placebo
This group takes 1,500 mg/day of placebo for 4 weeks. Participants were instructed to take one capsule orally three times daily, 30 minutes before each meal.
| Study group | Role | What they receive |
|---|---|---|
| Dihydroxydibutylether group | Experimental | This group takes dihydroxydibutylether for 4 weeks. Receives: Drug: Dihydroxydibutylether group |
| Control group | Placebo comparator | This group takes placebo for 4 weeks. Receives: Drug: Control group placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal symptom total score at 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.
Measured: 4 weeks
Secondary outcomes (4)
The Korean version of the Nepean Dyspepsia Index total score at 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.
Measured: 4 weeks
gastrointestinal symptom total score at 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.
Measured: 2 weeks
Seven-point Likert scale for overall treatment efficacy at 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.
Measured: 4 weeks
each gastrointestinal symptom score at 2, 4 weeks
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.
Measured: 2, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start25 Feb 2022
- Primary completion5 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ChoA Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199441
- Sponsor's protocol ID
- 02-2021-034
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05199441
- Acronym / sponsor ID
- 02-2021-034
- Conditions
- Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Collaborators
- ChoA Pharmaceutical Co., Ltd.
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dihydroxydibutylether group | Experimental | Drug: Dihydroxydibutylether groupThis group takes dihydroxydibutylether for 4 weeks. |
| Control group | Placebo comparator | Drug: Control group placeboThis group takes placebo for 4 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (35 listed)
- Those who have confirmed the following medical history or surgical history at the time of screening
- Those with the following diseases at the time of screening
- Those who have administered the following drugs that may affect efficacy evaluation within 2 weeks before screening
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dihydroxydibutylether groupAlso: Galeo® groupThis group takes 1.500 mg/day of dihydroxydibutylether for 4 weeks. Participants were instructed to take one capsule orally three times daily, 30 minutes before each meal. | Drug | Dihydroxydibutylether group |
| Control group placeboAlso: PlaceboThis group takes 1,500 mg/day of placebo for 4 weeks. Participants were instructed to take one capsule orally three times daily, 30 minutes before each meal. | Drug | Control group |
Primary outcome
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 secondary outcomes
The Korean version of the Nepean Dyspepsia Index total score at 4 weeks
Time frame: 4 weeks
gastrointestinal symptom total score at 2 weeks
Time frame: 2 weeks
Seven-point Likert scale for overall treatment efficacy at 4 weeks
Time frame: 4 weeks
each gastrointestinal symptom score at 2, 4 weeks
Time frame: 2, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dihydroxydibutylether group in people with Dyspepsia, run by Pusan National University Yangsan Hospital at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal symptom total score at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.