A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02567578
Recruitment Status :
(due to dose re-selection)
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects must be willing and able to provide written informed consent.
BMI of < 35 kg/m2
Patients experiencing one or more of functional dyspepsia symptoms beginning at least 6 months prior according to Rome III criteria, with the symptom(s) evident over the last 3 months at the time of screening
Patients with no evidence of organic lesions based on upper GI endoscopy, which could be the cause of dyspeptic symptoms
Women of childbearing potential (WOCBP) must have a negative pregnancy test result at the screening visit and use an adequate method of contraception to avoid pregnancy throughout the study
Women who are pregnant or breastfeeding.
Women with a positive pregnancy test result on enrollment or prior to investigational product administration.
Subjects with a history of surgery that could affect gastrointestinal motility
Subjects with inflammatory bowel disease
Clinically significant chronic infection (eg. AIDS, etc), or significant medical or psychiatric illness.
Serious cardiovascular disease (including QT prolongation defined as QTc interval ≥ 450msec) or respiratory disease
History of alcohol or drug abuse within the previous one year.
Subjects with mental illness (e.g. schizophrenia, dementia etc) that may render the inability to complete the study
Physical and Laboratory Test Findings
Administration of any other investigational product or participation in other clinical trials within 3 months prior to randomization.