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A Study to Demonstrate the Efficacy and Safety of Motilitone®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01817465
Recruitment Status : Completed
First Posted : March 25, 2013
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Study Description
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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®.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Motilitone ® Drug: Pantoline® Drug: Motilitone® and Pantoline® Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-centers, Randomized, Double-blinded, Parallel Study Study to Evaluate the Efficacy and Safety of Motilitone® in Patients With Functional Dyspepsia.
Study Start Date : August 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arms and Interventions
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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®


Outcome Measures
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Primary Outcome Measures :
  1. 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



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

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817465


Locations
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Korea, Republic of
Ajou University Medical Center
Suwon, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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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
More Information
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01817465    
Other Study ID Numbers: DA9701_PPI_IV
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive