CompletedPhase 4

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

South Korea226 participantsStarted 2022-02-25

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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)
. Organic causes of gastroparesis (diabetic gastroparesis, etc.)
. glaucoma
. urinary tract disease or prostate disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

gastrointestinal symptom total score at 4 weeks

Timeframe: 4 weeks

Trial details

NCT IDNCT05199441

SponsorPusan National University Yangsan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-05

View on ClinicalTrials.gov More Dyspepsia trials