Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
NCT ID: NCT02831543
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
354 participants
INTERVENTIONAL
2016-04-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Motireb 5/100 mg t.i.d
Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Motireb 5/100 mg
Mosapride citrate t.i.d
Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d
Mosapride citrate
Placebo t.i.d
Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Placebo
Interventions
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Motireb 5/100 mg
Mosapride citrate
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Patient with functional dyspepsia met the ROME III criteria or symptom assessment form
Exclusion Criteria
2. Patients with previous gastrointestinal surgery
3. Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
4. Patients with history of gastrointestinal cancer
5. Patients with pancreatic disease (pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease, acute gastritis.
6. Patients with Zollinger-Ellison syndrome
7. Patients with irritable bowel syndrome
8. Pregnant or lactating women
9. Patients with hepatic abnormality
10. Patients with renal dysfunction or chronic kidney disease
11. Patients who are judged by the investigators to be unsuitable to participate in the clinical trial.
19 Years
ALL
No
Sponsors
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IlDong Pharmaceutical Co Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Nayoung Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam, Kyung-gi, South Korea
Countries
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Central Contacts
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Facility Contacts
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Nayoung Kim, PhD, MD
Role: primary
Other Identifiers
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ID-REMO-301
Identifier Type: -
Identifier Source: org_study_id
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