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A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT02567578•Yuhan Corporation

View on ClinicalTrials.gov

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Samsung seoul hospital

Seoul, South Korea

Key Dates

Start Date

October 1, 2015

Primary Completion Date

March 16, 2017

Completion Date

March 16, 2017

Last Updated

January 13, 2022

Enrollment

ACTUAL participants

Conditions

Functional Dyspepsia

Interventions

YH12852 0.1 mg

DRUG

YH12852 0.25 mg

DRUG

YH12852 0.5 mg

DRUG

Placebo

DRUG

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

NCT07182890

Functional DyspepsiaProbiotics+2 more

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RECRUITING

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

NCT07196735

Functional DyspepsiaBIA+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

The Brain-Heart-Gut Connection

Enabling Microbiomics- Driven Personalized Nutrition

Cerebral Cortical Influences on Autonomic Function

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia