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

NCT02567578 | Terminated Phase 2

• 1 other identifier: YH12852-201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Ratio of OTE (Overall Treatment Efficacy) responders

  4 weeks

Secondary Outcomes (3)

• Ratio of OSS responders

  4 weeks

• Elimination rate for 8 functional dyspepsia symptoms

  4 weeks

• Change from basline in NDI QoL score

  4 weeks

Study Arms (4)

YH12852 0.1 mg

EXPERIMENTAL

twice daily for 4 weeks

Drug: YH12852 0.1 mg

YH12852 0.25 mg

EXPERIMENTAL

twice daily for 4 weeks

Drug: YH12852 0.25 mg

YH12852 0.5 mg

EXPERIMENTAL

twice daily for 4 weeks

Drug: YH12852 0.5 mg

Placebo

PLACEBO COMPARATOR

twice daily for 4 weeks

Drug: Placebo

Interventions

YH12852 0.1 mg DRUG

YH12852 0.1 mg

YH12852 0.25 mg DRUG

YH12852 0.25 mg

YH12852 0.5 mg DRUG

YH12852 0.5 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be willing and able to provide written informed consent.
• BMI of \< 35 kg/m2
• 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
• Patients with no evidence of organic lesions based on upper GI endoscopy, which could be the cause of dyspeptic symptoms
• 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

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test result on enrollment or prior to investigational product administration.
• Subjects with a history of surgery that could affect gastrointestinal motility
• Subjects with inflammatory bowel disease
• Clinically significant chronic infection (eg. AIDS, etc), or significant medical or psychiatric illness.
• Serious cardiovascular disease (including QT prolongation defined as QTc interval ≥ 450msec) or respiratory disease
• History of alcohol or drug abuse within the previous one year.
• Subjects with mental illness (e.g. schizophrenia, dementia etc) that may render the inability to complete the study
• Physical and Laboratory Test Findings
• Administration of any other investigational product or participation in other clinical trials within 3 months prior to randomization.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Samsung seoul hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

YH12852

Study Officials

• Poong Lyul Lee, MD, Ph.D

  Samsung seoul hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2015
• Primary Completion: March 16, 2017
• Study Completion: March 16, 2017
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

KR (1)