Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02567578
Recruitment Status : Suspended (due to dose re-selection)
First Posted : October 5, 2015
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: YH12852 0.1 mg Drug: YH12852 0.25 mg Drug: YH12852 0.5 mg Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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



Primary Outcome Measures :
  1. Ratio of OTE (Overall Treatment Efficacy) responders [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Ratio of OSS responders [ Time Frame: 4 weeks ]
  2. Elimination rate for 8 functional dyspepsia symptoms [ Time Frame: 4 weeks ]
  3. Change from basline in NDI QoL score [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567578


Locations
Layout table for location information
Korea, Republic of
Samsung seoul hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
Layout table for investigator information
Principal Investigator: Poong Lyul Lee, MD, Ph.D Samsung seoul hospital

Layout table for additonal information
Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02567578     History of Changes
Other Study ID Numbers: YH12852-201
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
YH12852
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs