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

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02567578
• Other study ID #: YH12852-201
• Status: Terminated
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: March 16, 2017

Study information

• Verified date: December 2021
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 16, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Drug:
• YH12852 0.1 mg

• YH12852 0.25 mg

• YH12852 0.5 mg

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Samsung seoul hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of OTE (Overall Treatment Efficacy) responders		4 weeks
Secondary	Ratio of OSS responders		4 weeks
Secondary	Elimination rate for 8 functional dyspepsia symptoms		4 weeks
Secondary	Change from basline in NDI QoL score		4 weeks