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

NCT ID: NCT02567578

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-03-16

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.

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

YH12852 0.1 mg

twice daily for 4 weeks

Group Type: EXPERIMENTAL

YH12852 0.1 mg

Intervention Type: DRUG

YH12852 0.25 mg

twice daily for 4 weeks

Group Type: EXPERIMENTAL

YH12852 0.25 mg

Intervention Type: DRUG

YH12852 0.5 mg

twice daily for 4 weeks

Group Type: EXPERIMENTAL

YH12852 0.5 mg

Intervention Type: DRUG

Placebo

twice daily for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

YH12852 0.1 mg

Intervention Type: DRUG

YH12852 0.25 mg

Intervention Type: DRUG

YH12852 0.5 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Poong Lyul Lee, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung seoul hospital

Locations

Samsung seoul hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YH12852-201

Identifier Type: -

Identifier Source: org_study_id