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

Yuhan Corporation1 site in 1 country12 target enrollmentOctober 2015

ConditionsFunctional Dyspepsia

InterventionsYH12852 0.1 mg YH12852 0.25 mg YH12852 0.5 mg Placebo

DrugsYH12852 0.1 mg YH12852 0.25 mg YH12852 0.5 mg Placebo

Overview

Phase: Phase 2
Intervention: YH12852 0.1 mg
Conditions: Functional Dyspepsia
Sponsor: Yuhan Corporation
Enrollment: 12
Locations: 1
Primary Endpoint: Ratio of OTE (Overall Treatment Efficacy) responders
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

March 16, 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yuhan Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.