Back to resultsEfficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWJ1252
Gasmotin
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria:
- Male of 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
- Hanyang University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DWJ1252
Gasmotin
Arm Description
DWJ1252 + Placebo of Gasmotin
Gasmotin + Placebo of DWJ1252
Outcomes
Primary Outcome Measures
The change from baseline in GIS (Gastrointestinal Symptom Score)
Secondary Outcome Measures
Full Information
NCT ID
NCT03024086
First Posted
December 29, 2016
Last Updated
June 25, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT03024086
Brief Title
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia
Official Title
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 1)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
April 25, 2017 (Actual)
Study Completion Date
April 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
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 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DWJ1252
Arm Type
Experimental
Arm Description
DWJ1252 + Placebo of Gasmotin
Arm Title
Gasmotin
Arm Type
Active Comparator
Arm Description
Gasmotin + Placebo of DWJ1252
Intervention Type
Drug
Intervention Name(s)
DWJ1252
Intervention Description
DWJ1252 and Placebo of Gasmotin
Intervention Type
Drug
Intervention Name(s)
Gasmotin
Intervention Description
Gasmotin and Placebo of DWJ1252
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 of 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
Facility Information:
Facility Name
Hanyang University 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
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