NCT01817465

Brief Summary

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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1.6 years

First QC Date

March 19, 2013

Last Update Submit

January 25, 2015

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Subject global assessment by using 5-Likert scale and Binary outcome methods

    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 Outcomes (3)

  • Number of dyspepsia(indigestion) symptoms occurred (Counted daily)

    6 weeks

  • Assessment of NDI-K Quality of Life

    6 weeks

  • Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5

    6 weeks

Study Arms (3)

Motilione®

EXPERIMENTAL

30 mg is administered with a tablet of placebo (Pantoline®)

Drug: Motilitone ®

Pantoline®

ACTIVE COMPARATOR

40mg is administered with a tablet of Motilitone®

Drug: Pantoline®

Motilitone® and Pantoline®

ACTIVE COMPARATOR

Both drugs are administered at once

Drug: Motilitone® and Pantoline®

Interventions

Motilitone ®DRUG
Motilione®
Pantoline®DRUG
Pantoline®
Motilitone® and Pantoline®DRUG
Motilitone® and Pantoline®

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Medical Center

Suwon, South Korea

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 25, 2013

Study Start

August 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

KR(1)