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Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients. | Clinical Trials | Clareo Health

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Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.

NCT02831543•IlDong Pharmaceutical Co Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

Seoul National University Bundang Hospital

Seongnam, Kyung-gi, South Korea

Key Dates

Start Date

April 1, 2016

Primary Completion Date

January 1, 2017

Completion Date

June 1, 2017

Last Updated

July 13, 2016

Enrollment

354

ESTIMATED participants

Conditions

Functional Dyspepsia

Interventions

Motireb 5/100 mg

DRUG

Mosapride citrate

DRUG

Placebo

DRUG

Contacts

Min-Hee Kwon

CONTACT

82-2-526-3379 minhee@ildong.com

Yoan Park, Master

CONTACT

82-2-526-3524 yapark@ildong.com

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.

Inclusion Criteria

Exclusion Criteria

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

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Cerebral Cortical Influences on Autonomic Function

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia