Clinical trial NCT02567578: A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Functional Dyspepsia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Ratio of OTE (Overall Treatment Efficacy) responders
timeFrame: 4 weeks
Secondary outcomes:
measure: Ratio of OSS responders
timeFrame: 4 weeks
measure: Elimination rate for 8 functional dyspepsia symptoms
timeFrame: 4 weeks
measure: Change from basline in NDI QoL score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung seoul hospital
Study officials:
affiliation: Samsung seoul hospital
name: Poong Lyul Lee, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: