- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05842408
Phase III Clinical Trial of DA-5212 in Patients With Functional Dyspepsia
April 24, 2023 updated by: Dong-A ST Co., Ltd.
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients With Functional Dyspepsia
This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
380
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Seok-chae Choi, PhD
- Phone Number: 063-859-2550
- Email: medcsc@wku.ac.kr
Study Locations
-
-
Muwangro 895
-
Iksan, Muwangro 895, Korea, Republic of, 54538
- Wonkwang University Hospital
-
Contact:
- Seok-chae Choi, PhD
- Phone Number: 063-859-2550
- Email: medcsc@wku.ac.kr
-
Principal Investigator:
- medcsc@wku.ac.kr Choi, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DA-5212
administered once daily for 4weeks
|
Test drug: DA-5212
|
Other: DA-5212-R
administered once daily for 4weeks
|
Control drug: DA-5212-R
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in NDI-K functional dyspepsia score
Time Frame: Change from baseline at 4 weeks
|
Change from baseline at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in overall treatment score of patients
Time Frame: Change from baseline at 4 weeks
|
Change from baseline at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2023
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
April 24, 2023
First Submitted That Met QC Criteria
April 24, 2023
First Posted (Estimate)
May 4, 2023
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
April 24, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA5212_FDQ_III
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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