Back to resultsEfficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)
Primary Purpose
Functional Dyspepsia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWJ1252
Gasmotin
Placebo of Gasmotin
Placebo of DWJ1252
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria:
- Male and female of at least 19 years old
- Patient with functional dyspepsia met the ROME III criteria
Exclusion Criteria:
- Patients with previous gastrointestinal surgery
- Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
- Patients with history of gastrointestinal cancer
Sites / Locations
- Smg-Snu Boramae Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DWJ1252
Gasmotin
Arm Description
Outcomes
Primary Outcome Measures
The change from baseline in GIS (Gastrointestinal Symptom Score)
Secondary Outcome Measures
Full Information
NCT ID
NCT03184402
First Posted
June 9, 2017
Last Updated
June 25, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT03184402
Brief Title
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)
Official Title
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 2)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWJ1252
Arm Type
Experimental
Arm Title
Gasmotin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DWJ1252
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Gasmotin
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Placebo of Gasmotin
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Placebo of DWJ1252
Intervention Description
tablet
Primary Outcome Measure Information:
Title
The change from baseline in GIS (Gastrointestinal Symptom Score)
Time Frame
At 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female of at least 19 years old
Patient with functional dyspepsia met the ROME III criteria
Exclusion Criteria:
Patients with previous gastrointestinal surgery
Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
Patients with history of gastrointestinal cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SMG-SNU BORAMAE MEDICAL CENTER
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Smg-Snu Boramae Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)
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