Back to resultsPhase III Clinical Trial of DA-5212 in Patients With Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Not yet recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-5212
DA-5212-R
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria: Men or women ≥ 19 years of age Patients who diagnosed with functional dyspepsia Patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit Exclusion Criteria: Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit Patients with hypersensitivity to investigational drugs and similar drugs Pregnant or breastfeeding women
Sites / Locations
- Wonkwang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
DA-5212
DA-5212-R
Arm Description
administered once daily for 4weeks
administered once daily for 4weeks
Outcomes
Primary Outcome Measures
Change in NDI-K functional dyspepsia score
Secondary Outcome Measures
Change in overall treatment score of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05842408
Brief Title
Phase III Clinical Trial of DA-5212 in Patients With Functional Dyspepsia
Official Title
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients With Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST 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
No
5. Study Description
Brief Summary
This study is to evaluate efficacy and safety of DA-5212 in patients with 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
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DA-5212
Arm Type
Experimental
Arm Description
administered once daily for 4weeks
Arm Title
DA-5212-R
Arm Type
Other
Arm Description
administered once daily for 4weeks
Intervention Type
Drug
Intervention Name(s)
DA-5212
Intervention Description
Test drug: DA-5212
Intervention Type
Drug
Intervention Name(s)
DA-5212-R
Intervention Description
Control drug: DA-5212-R
Primary Outcome Measure Information:
Title
Change in NDI-K functional dyspepsia score
Time Frame
Change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Change in overall treatment score of patients
Time Frame
Change from baseline at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women ≥ 19 years of age
Patients who diagnosed with functional dyspepsia
Patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit
Exclusion Criteria:
Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit
Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit
Patients with hypersensitivity to investigational drugs and similar drugs
Pregnant or breastfeeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seok-chae Choi, PhD
Phone
063-859-2550
Email
medcsc@wku.ac.kr
Facility Information:
Facility Name
Wonkwang University Hospital
City
Iksan
State/Province
Muwangro 895
ZIP/Postal Code
54538
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seok-chae Choi, PhD
Phone
063-859-2550
Email
medcsc@wku.ac.kr
First Name & Middle Initial & Last Name & Degree
medcsc@wku.ac.kr Choi, PhD
12. IPD Sharing Statement
Learn more about this trial
Phase III Clinical Trial of DA-5212 in Patients With Functional Dyspepsia
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