Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
1 other identifier
interventional
354
1 country
1
Brief Summary
A phase â…¢, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 13, 2016
July 1, 2016
9 months
July 11, 2016
July 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The responder ratio of GOS(Global Overall Symptom)
at the 4th week
Study Arms (3)
Motireb 5/100 mg t.i.d
EXPERIMENTALMotireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Mosapride citrate t.i.d
ACTIVE COMPARATORPlacebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d
Placebo t.i.d
PLACEBO COMPARATORPlacebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Interventions
Eligibility Criteria
You may qualify if:
- Male and female aged 19 years or older
- Patient with functional dyspepsia met the ROME III criteria or symptom assessment form
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, Kyung-gi, South Korea
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Nayoung Kim, M.D., Ph.D.
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2016
First Posted
July 13, 2016
Study Start
April 1, 2016
Primary Completion
January 1, 2017
Study Completion
June 1, 2017
Last Updated
July 13, 2016
Record last verified: 2016-07