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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

Motireb 5/100 mg

Intervention Type DRUG

Mosapride citrate t.i.d

Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d

Group Type ACTIVE_COMPARATOR

Mosapride citrate

Intervention Type DRUG

Placebo t.i.d

Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Motireb 5/100 mg

Intervention Type DRUG

Mosapride citrate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female aged 19 years or older
2. Patient with functional dyspepsia met the ROME III criteria or symptom assessment form

Exclusion Criteria

1. Patient with peptic ulcer or gastroesophageal reflux disease
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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Min-Hee Kwon

Role: CONTACT

82-2-526-3379

Yoan Park, Master

Role: CONTACT

82-2-526-3524

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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