A Study to Demonstrate the Efficacy and Safety of Motilitone®

January 25, 2015 updated by: Dong-A ST Co., Ltd.

A Multi-centers, Randomized, Double-blinded, Parallel Study Study to Evaluate the Efficacy and Safety of Motilitone® in Patients With Functional Dyspepsia.

This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in treatment of the patients with functional dyspepsia. The study is conducted with following methods: multi-centers, double blind, randomization, parallel. The subjects will receive Motilitone® or/and Pantoline®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Roman III criteria
  • One or more conditions are applied: epigastralgia, burning feelings in the solar plexus early satiety, uncomfortable fullness
  • No organic lesion

Exclusion Criteria:

  • has been administered or was administered within a month
  • had a surgery that might affect gastrointestinal motility
  • Tegaserod

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: Motilione®
30 mg is administered with a tablet of placebo (Pantoline®)
Drug: Motilitone ®
Active Comparator: Pantoline®
40mg is administered with a tablet of Motilitone®
Drug: Pantoline®
Active Comparator: Motilitone® and Pantoline®
Both drugs are administered at once
Drug: Motilitone® and Pantoline®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject global assessment by using 5-Likert scale and Binary outcome methods
Time Frame: 6 weeks

5-Likert scale: 0: worse

  1. similar
  2. improved in some degree
  3. considerably improved
  4. completely cured

Binary outcome:

yes/no
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of dyspepsia(indigestion) symptoms occurred (Counted daily)
Time Frame: 6 weeks
6 weeks
Assessment of NDI-K Quality of Life
Time Frame: 6 weeks
6 weeks
Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Myung Kyu Choi, M.D., Ph.D., The Catholic University of Korea
  • Principal Investigator: Kyu Chan Huh, M.D., Ph.D., Konyang University Hospital
  • Principal Investigator: Sung Kook Kim, M.D., Ph.D., Kyungpook National University Hospital
  • Principal Investigator: Kyung Sik Park, M.D., Ph.D., Keimyung University Dongsan Medical Center
  • Principal Investigator: Joong Gu Gweon, M.D.,Ph.D., Daegu Catholic University Medical Center
  • Principal Investigator: Geun Am Song, M.D., Ph.D., Busan National University Hospital
  • Principal Investigator: Soo Jin Hong, M.D., Ph.D., Soonchunhyang University Hospital
  • Principal Investigator: Na Young Kim, M.D., Ph.D., Seoul National University Bundang Hospital
  • Principal Investigator: Jung Il Son, M.D., Ph.D., Kangbuk Samsung Hospital
  • Principal Investigator: Poong Yul Lee, M.D., Ph.D., Samsung Medical Center
  • Principal Investigator: Joon Sung Lee, M.D., Ph.D., Soonchunhyang University Hospital
  • Principal Investigator: Hoon Yong Jung, M.D., Ph.D., Asan Medical Center
  • Principal Investigator: Hyo Jin Park, M.D., Ph.D., Gangnam Severance Hospital
  • Principal Investigator: Yong Chan Lee, M.D., Ph.D., Severance Hospital
  • Principal Investigator: Suk Chae Choi, M.D., Ph.D., Wonkwang Medical Center
  • Principal Investigator: Hye Kyung Jung, M.D., Ph.D., Iwha Womans Unversity Mokdong Hospital
  • Principal Investigator: Sam Ryong Ji, M.D., Ph.D., Inje University
  • Principal Investigator: Jong Sun Ryu, M.D., Ph.D., Chonnam National University Hospital
  • Principal Investigator: Oh Young Lee, M.D., Ph.D., Hanyang University

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

August 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 25, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA9701_PPI_IV

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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