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

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.

Study Overview

• Status: Terminated
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Drug: Placebo; Drug: YH12852 0.1 mg; Drug: YH12852 0.25 mg; Drug: YH12852 0.5 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YH12852 0.1 mg; twice daily for 4 weeks	Drug: YH12852 0.1 mg
Experimental: YH12852 0.25 mg; twice daily for 4 weeks	Drug: YH12852 0.25 mg
Experimental: YH12852 0.5 mg; twice daily for 4 weeks	Drug: YH12852 0.5 mg
Placebo Comparator: Placebo; twice daily for 4 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of OTE (Overall Treatment Efficacy) responders	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Ratio of OSS responders	4 weeks
Elimination rate for 8 functional dyspepsia symptoms	4 weeks
Change from basline in NDI QoL score	4 weeks

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Poong Lyul Lee, MD, Ph.D, Samsung Seoul Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 16, 2017
• Study Completion (Actual): March 16, 2017

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Serotonin 5-HT4 Receptor Agonists; YH12852
• Other Study ID Numbers: YH12852-201