Back to resultsClinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
Primary Purpose
Functional Dyspepsia
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Motireb 5/100 mg
Mosapride citrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria:
- Male and female aged 19 years or older
- Patient with functional dyspepsia met the ROME III criteria or symptom assessment form
Exclusion Criteria:
- 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.
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Motireb 5/100 mg t.i.d
Mosapride citrate t.i.d
Placebo t.i.d
Arm Description
Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d
Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Outcomes
Primary Outcome Measures
The responder ratio of GOS(Global Overall Symptom)
Secondary Outcome Measures
Full Information
NCT ID
NCT02831543
First Posted
July 11, 2016
Last Updated
July 11, 2016
Sponsor
IlDong Pharmaceutical Co Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02831543
Brief Title
Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
354 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motireb 5/100 mg t.i.d
Arm Type
Experimental
Arm Description
Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Arm Title
Mosapride citrate t.i.d
Arm Type
Active Comparator
Arm Description
Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d
Arm Title
Placebo t.i.d
Arm Type
Placebo Comparator
Arm Description
Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Intervention Type
Drug
Intervention Name(s)
Motireb 5/100 mg
Intervention Type
Drug
Intervention Name(s)
Mosapride citrate
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The responder ratio of GOS(Global Overall Symptom)
Time Frame
at the 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female aged 19 years or older
Patient with functional dyspepsia met the ROME III criteria or symptom assessment form
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Hee Kwon
Phone
82-2-526-3379
Email
minhee@ildong.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yoan Park, Master
Phone
82-2-526-3524
Email
yapark@ildong.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayoung Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seong Nam
State/Province
Kyung-gi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayoung Kim, PhD, MD
First Name & Middle Initial & Last Name & Degree
Nayoung Kim, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
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