This is a multicenter, randomized, double-blind, placebo-controlled dose-finding phase 2 trial to evaluate the efficacy and safety of YH12852 in patients with functional dyspepsia.
Eligible subjects will be randomized into one of 4 groups; YH12852 0.1 mg, 0.25 mg, 0.5 mg, or placebo at the same ratio and will be administered investigational products orally, twice daily for 4 weeks and followed up for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
Samsung seoul hospital
Seoul, South Korea
Ratio of OTE (Overall Treatment Efficacy) responders
Time frame: 4 weeks
Ratio of OSS responders
Time frame: 4 weeks
Elimination rate for 8 functional dyspepsia symptoms
Time frame: 4 weeks
Change from basline in NDI QoL score
Time frame: 4 weeks
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