Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients with Functional Dyspepsia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05842408

Enrollment

384

Registered

2023-05-06

Start date

2023-06-06

Completion date

2024-09-04

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Brief summary

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

Interventions

DRUGDA-5212

Test drug: DA-5212

DRUGDA-5212-R

Control drug: DA-5212-R

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026