Clinical trial NCT01817465: A Study to Demonstrate the Efficacy and Safety of Motilitone®
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Dyspepsia
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-25
Enrollment: 389
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.


Eligibility 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

Primary outcomes:
measure: Subject global assessment by using 5-Likert scale and Binary outcome methods
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of dyspepsia(indigestion) symptoms occurred (Counted daily)
timeFrame: 6 weeks
measure: Assessment of NDI-K Quality of Life
timeFrame: 6 weeks
measure: Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
Study officials:
affiliation: The Catholic University of Korea
name: Myung Kyu Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konyang University Hospital
name: Kyu Chan Huh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Sung Kook Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: Kyung Sik Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Catholic University Medical Center
name: Joong Gu Gweon, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Busan National University Hospital
name: Geun Am Song, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Soo Jin Hong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Na Young Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangbuk Samsung Hospital
name: Jung Il Son, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Poong Yul Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Joon Sung Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Hoon Yong Jung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangnam Severance Hospital
name: Hyo Jin Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Yong Chan Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang Medical Center
name: Suk Chae Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Iwha Womans Unversity Mokdong Hospital
name: Hye Kyung Jung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Sam Ryong Ji, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Jong Sun Ryu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Oh Young Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: