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

Primary Purpose

Dyspepsia

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dihydroxydibutylether group
Control group placebo
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    1. Surgery that may affect gastrointestinal motility (eg, laparoscopic or laparotomy of the gastrointestinal tract) (except for appendectomy and hysterectomy due to simple appendicitis)
    2. 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
    3. 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)
    4. 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)
    5. 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

    1. Organic causes of gastroparesis (diabetic gastroparesis, etc.)
    2. glaucoma
    3. urinary tract disease or prostate disease
    4. Biliary duct obstruction or biliary duct stones (eg, intrahepatic gallstones, extrahepatic gallstones)
    5. uncontrolled diabetes mellitus (glycated hemoglobin > 8.0%)
    6. 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
    7. Serum creatinine level is 1.5 times or more of the upper limit of normal, or renal disease
    8. 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

    1. emollient: artichoke extract, ursodeoxycholic acid, etc.
    2. prokinetics: metoclopramide, itopride, etc.
    3. inhibitors of gastric acid secretion: H2 receptor antagonist (proton pump inhibitor), gastric acid pump antagonist (acid pump antagonist)
    4. gastric mucosal protective agent, antacid, digestive agent
    5. fundus relaxants: sumatriptan, buspirone, etc.
    6. cholinergic, anticholinergic and antispasmodic
    7. psychotropic drugs: antipsychotic drugs, antidepressants, antimanic drugs, antianxiety drugs, hallucinogens, etc.
    8. Nonsteroidal anti-inflammatory drugs (intermittent administration up to 1 week 2 days and cyclooxygenase-2 selective inhibitors are acceptable)
    9. Antithrombotic agents (antiplatelet agents, anticoagulants)
    10. systemic glucocorticoids
    11. 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

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dihydroxydibutylether group

Control group

Arm Description

This group takes dihydroxydibutylether for 8 weeks.

This group takes placebo for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 17, 2021
Last Updated
April 10, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05199441
Brief Title
Efficacy of Galeo® in Patients With Postprandial Distress Syndrome Subtype in Functional Dyspepsia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dihydroxydibutylether group
Arm Type
Experimental
Arm Description
This group takes dihydroxydibutylether for 8 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Dihydroxydibutylether group
Other Intervention Name(s)
Galeo® group
Intervention Description
This group takes 1.500 mg/day of dihydroxydibutylether for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Control group placebo
Other Intervention Name(s)
Placebo
Intervention Description
This group takes 1,500 mg/day of placebo for 8 weeks.
Primary Outcome Measure Information:
Title
gastrointestinal symptom total score at 4 weeks
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The Korean version of the Nepean Dyspepsia Index total score at 4 weeks
Description
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.
Time Frame
4 weeks
Title
gastrointestinal symptom total score at 2 weeks
Description
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.
Time Frame
2 weeks
Title
Seven-point Likert scale for overall treatment efficacy at 4 weeks
Description
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.
Time Frame
4 weeks
Title
each gastrointestinal symptom score at 2, 4 weeks
Description
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.
Time Frame
2, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Yeoup Lee, MD, PhD
Phone
360-2860
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Li Lee
Phone
360-2860
Ext
055
Email
yeri1230@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Phone
360-2860
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name & Degree
Ye Li Lee
Phone
360-2869
Ext
055
Email
yeri1230@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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