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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
226
This group takes 1.500 mg/day of dihydroxydibutylether for 8 weeks.
This group takes 1,500 mg/day of placebo for 8 weeks.
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea
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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2, 4 weeks
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