Functional DyspepsiaPhase 3NCT02831543
Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
A Phase 3 study testing Motireb 5/100 mg and Mosapride citrate in people with Functional Dyspepsia, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in functional dyspepsia patients. 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?
- Motireb 5/100 mg and Mosapride citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Jun 2017
- Phase
- Phase 3
- 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
- Male and female aged 19 years or older
- Patient with functional dyspepsia met the ROME III criteria or symptom assessment form
Who cannot join
- Patient with peptic ulcer or gastroesophageal reflux disease
- Patients with previous gastrointestinal surgery
- Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
- Patients with history of gastrointestinal cancer
- Patients with pancreatic disease (pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease, acute gastritis.
- Patients with Zollinger-Ellison syndrome
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- Patients with irritable bowel syndrome
- Pregnant or lactating women
- Patients with hepatic abnormality
- Patients with renal dysfunction or chronic kidney disease
- Patients who are judged by the investigators to be unsuitable to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyung-gi
Nayoung Kim, PhD, MD
Nayoung Kim, M.D., Ph.D.
About this study
A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in functional dyspepsia patients.
- Conditions
- Functional Dyspepsia
- Being tested
- Motireb 5/100 mg, Mosapride citrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motireb 5/100 mgDrug
Mosapride citrateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Motireb 5/100 mg t.i.d | Experimental | Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d Receives: Drug: Motireb 5/100 mg |
| Mosapride citrate t.i.d | Active comparator | Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d Receives: Drug: Mosapride citrate |
| Placebo t.i.d | Placebo comparator | Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The responder ratio of GOS(Global Overall Symptom)
Measured: at the 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nayoung Kim, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831543
- Sponsor's protocol ID
- ID-REMO-301
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
- ClinicalTrials.gov ID
- NCT02831543
- Acronym / sponsor ID
- ID-REMO-301
- Conditions
- Functional Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 13 Jul 2016 (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.
A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in functional dyspepsia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motireb 5/100 mg t.i.d | Experimental | Drug: Motireb 5/100 mgMotireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d |
| Mosapride citrate t.i.d | Active comparator | Drug: Mosapride citratePlacebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d |
| Placebo t.i.d | Placebo comparator | Drug: PlaceboPlacebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female aged 19 years or older
- Patient with functional dyspepsia met the ROME III criteria or symptom assessment form
Key exclusion criteria (11 listed)
- Patient with peptic ulcer or gastroesophageal reflux disease
- Patients with previous gastrointestinal surgery
- Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
- Patients with history of gastrointestinal cancer
- Patients with pancreatic disease (pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease, acute gastritis.
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 |
|---|---|---|
| Motireb 5/100 mg | Drug | Motireb 5/100 mg t.i.d |
| Mosapride citrate | Drug | Mosapride citrate t.i.d |
| Placebo | Drug | Placebo t.i.d |
Primary outcome
The responder ratio of GOS(Global Overall Symptom)
Time frame: at the 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
Nayoung Kim, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motireb 5/100 mg and Mosapride citrate in people with Functional Dyspepsia, run by IlDong Pharmaceutical Co Ltd 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Jul 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Hee Kwon (82-2-526-3379, minhee@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The responder ratio of GOS(Global Overall Symptom) (time frame: at the 4th week). 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 Jul 2016.