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

Phase 2

Terminated

• Conditions: Functional Dyspepsia
• Interventions: Drug: YH12852 0.1 mg; Drug: YH12852 0.25 mg; Drug: YH12852 0.5 mg; Drug: Placebo

• Registration Number: NCT02567578
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Primary Completion: 2017-03-16
• Study Completion: 2017-03-16
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-26
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YH12852 0.1 mg	YH12852 0.1 mg	twice daily for 4 weeks
YH12852 0.25 mg	YH12852 0.25 mg	twice daily for 4 weeks
YH12852 0.5 mg	YH12852 0.5 mg	twice daily for 4 weeks
Placebo	Placebo	twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Ratio of OTE (Overall Treatment Efficacy) responders	4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung seoul hospital; 🇰🇷 Seoul, Korea, Republic of