Functional DyspepsiaPhase 2NCT02567578
A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia
A Phase 2 study testing YH12852 0.1 mg, YH12852 0.25 mg and YH12852 0.5 mg in people with Functional Dyspepsia, run by Yuhan Corporation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- YH12852 0.1 mg, YH12852 0.25 mg and YH12852 0.5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to 16 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- YH12852 0.1 mg, YH12852 0.25 mg, YH12852 0.5 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH12852 0.1 mgDrug
YH12852 0.25 mgDrug
YH12852 0.5 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| YH12852 0.1 mg | Experimental | twice daily for 4 weeks Receives: Drug: YH12852 0.1 mg |
| YH12852 0.25 mg | Experimental | twice daily for 4 weeks Receives: Drug: YH12852 0.25 mg |
| YH12852 0.5 mg | Experimental | twice daily for 4 weeks Receives: Drug: YH12852 0.5 mg |
| Placebo | Placebo comparator | twice daily for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of OTE (Overall Treatment Efficacy) responders
Measured: 4 weeks
Secondary outcomes (3)
Ratio of OSS responders
Measured: 4 weeks
Elimination rate for 8 functional dyspepsia symptoms
Measured: 4 weeks
Change from basline in NDI QoL score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion16 Mar 2017
- Study completion16 Mar 2017
Why it stopped: Technology transfer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Poong Lyul Lee, MD, Ph.D, Principal investigator, Samsung seoul hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567578
- Sponsor's protocol ID
- YH12852-201
- Status last verified
- Dec 2021
- First submitted
- 1 Oct 2015
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02567578
- Acronym / sponsor ID
- YH12852-201
- Conditions
- Functional Dyspepsia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technology transfer
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YH12852 0.1 mg | Experimental | Drug: YH12852 0.1 mgtwice daily for 4 weeks |
| YH12852 0.25 mg | Experimental | Drug: YH12852 0.25 mgtwice daily for 4 weeks |
| YH12852 0.5 mg | Experimental | Drug: YH12852 0.5 mgtwice daily for 4 weeks |
| Placebo | Placebo comparator | Drug: Placebotwice daily for 4 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Ratio of OTE (Overall Treatment Efficacy) responders
Time frame: 4 weeks
3 secondary outcomes
Ratio of OSS responders
Time frame: 4 weeks
Elimination rate for 8 functional dyspepsia symptoms
Time frame: 4 weeks
Change from basline in NDI QoL score
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Technology transfer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poong Lyul Lee, MD, Ph.D principal investigator
Samsung seoul hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YH12852 0.1 mg, YH12852 0.25 mg and YH12852 0.5 mg in people with Functional Dyspepsia, run by Yuhan Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Technology transfer). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of OTE (Overall Treatment Efficacy) responders (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.