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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.
Full 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.
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Inclusion criteria
Exclusion criteria
Those who have confirmed the following medical history or surgical history at the time of screening
Those with the following diseases at the time of screening
Those who have administered the following drugs that may affect efficacy evaluation within 2 weeks before screening
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
Primary purpose
Allocation
Interventional model
Masking
226 participants in 2 patient groups, including a placebo group
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Central trial contact
Ye Li Lee; Sang Yeoup Lee, MD, PhD
Data sourced from clinicaltrials.gov
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