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

NCT05199441 | Completed Phase 4

• 1 other identifier: 02-2021-034
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (4)

• The Korean version of the Nepean Dyspepsia Index total score at 4 weeks

  4 weeks

• gastrointestinal symptom total score at 2 weeks

  2 weeks

• Seven-point Likert scale for overall treatment efficacy at 4 weeks

  4 weeks

• each gastrointestinal symptom score at 2, 4 weeks

  2, 4 weeks

Study Arms (2)

Dihydroxydibutylether group

EXPERIMENTAL

This group takes dihydroxydibutylether for 8 weeks.

Drug: Dihydroxydibutylether group

Control group

PLACEBO COMPARATOR

This group takes placebo for 8 weeks.

Drug: Control group placebo

Interventions

Dihydroxydibutylether group DRUG

This group takes 1.500 mg/day of dihydroxydibutylether for 8 weeks.

Also known as: Galeo® group

Dihydroxydibutylether group

Control group placebo DRUG

This group takes 1,500 mg/day of placebo for 8 weeks.

Also known as: Placebo

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang Yeoup Lee, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 20, 2022
• Study Start: February 25, 2022
• Primary Completion: July 5, 2023
• Study Completion: July 7, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)