Clinical Trial of DA-5212 in Patients with Functional Dys... | NCT05842408

Studies
Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

NCT05842408

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Dec 13, 2024Actual

Enrollment

384Actual

Phase

Phase 3

Conditions

Functional Dyspepsia

Interventions

DA-5212
DA-5212-R

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2023Actual

Primary Completion Date

Sep 4, 2024Actual

Completion Date

Sep 4, 2024Actual

First Submitted Date

Apr 24, 2023

First Submission Date that Met QC Criteria

Apr 24, 2023

First Posted Date

May 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2024

Last Update Posted Date

Dec 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

384Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DA-5212	Experimental	administered once daily for 4weeks	Drug: DA-5212
DA-5212-R	Other	administered once daily for 4weeks	Drug: DA-5212-R

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-5212	Drug	Test drug: DA-5212	DA-5212
DA-5212-R

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in NDI-K functional dyspepsia score		Change from baseline at 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in overall treatment score of patients		Change from baseline at 4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wonkwang University Hospital		Iksan	Muwangro 895	54538	South Korea