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

July 11, 2016 updated by: IlDong Pharmaceutical Co Ltd
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

354

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Kyung-gi
      • Seong Nam, Kyung-gi, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Nayoung Kim, PhD, MD
        • Principal Investigator:
          • Nayoung Kim, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motireb 5/100 mg t.i.d
Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Drug: Motireb 5/100 mg
Active Comparator: Mosapride citrate t.i.d
Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d
Drug: Mosapride citrate
Placebo Comparator: Placebo t.i.d
Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The responder ratio of GOS(Global Overall Symptom)
Time Frame: at the 4th week
at the 4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IlDong Pharmaceutical Co Ltd

Investigators

  • Principal Investigator: Nayoung Kim, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-REMO-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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