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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	Dihydroxydibutylether group	This group takes 1.500 mg/day of dihydroxydibutylether for 8 weeks.
DRUG	Control group placebo	This group takes 1,500 mg/day of placebo for 8 weeks.

Timeline

• Start date: 2022-02-25
• Primary completion: 2023-07-05
• Completion: 2023-07-07
• First posted: 2022-01-20
• Last updated: 2024-01-18

Locations

1 site across 1 country: South Korea