NCT05842408

Brief Summary

This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

April 24, 2023

Last Update Submit

December 10, 2024

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Change in NDI-K functional dyspepsia score

    Change from baseline at 4 weeks

Secondary Outcomes (1)

  • Change in overall treatment score of patients

    Change from baseline at 4 weeks

Study Arms (2)

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

DA-5212DRUG

Test drug: DA-5212

DA-5212
DA-5212-RDRUG

Control drug: DA-5212-R

DA-5212-R

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonkwang University Hospital

Iksan, Muwangro 895, 54538, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 6, 2023

Study Start

June 6, 2023

Primary Completion

September 4, 2024

Study Completion

September 4, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations

KR(1)