Overview

A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia

Status:
Suspended
Trial end date:
2020-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yuhan Corporation
Treatments:
YH12852
Criteria
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.