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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02567578
Other study ID # YH12852-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 2015
Est. completion date March 16, 2017

Study information

Verified date December 2021
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date March 16, 2017
Est. primary completion date March 16, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Subjects must be willing and able to provide written informed consent. 2. BMI of < 35 kg/m2 3. 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 4. Patients with no evidence of organic lesions based on upper GI endoscopy, which could be the cause of dyspeptic symptoms 5. 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 Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Women with a positive pregnancy test result on enrollment or prior to investigational product administration. 3. Subjects with a history of surgery that could affect gastrointestinal motility 4. Subjects with inflammatory bowel disease 5. Clinically significant chronic infection (eg. AIDS, etc), or significant medical or psychiatric illness. 6. Serious cardiovascular disease (including QT prolongation defined as QTc interval = 450msec) or respiratory disease 7. History of alcohol or drug abuse within the previous one year. 8. Subjects with mental illness (e.g. schizophrenia, dementia etc) that may render the inability to complete the study 9. Physical and Laboratory Test Findings 10. Administration of any other investigational product or participation in other clinical trials within 3 months prior to randomization.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
YH12852 0.1 mg

YH12852 0.25 mg

YH12852 0.5 mg

Placebo


Locations

Country Name City State
Korea, Republic of Samsung seoul hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ratio of OTE (Overall Treatment Efficacy) responders 4 weeks
Secondary Ratio of OSS responders 4 weeks
Secondary Elimination rate for 8 functional dyspepsia symptoms 4 weeks
Secondary Change from basline in NDI QoL score 4 weeks
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