Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

Phase 3CompletedNCT05842408

Dong-A ST Co., Ltd.384 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

384

Conditions

Functional Dyspepsia

Interventions

DA-5212DRUG

Test drug: DA-5212

DA-5212-RDRUG

Control drug: DA-5212-R

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Wonkwang University Hospital

Iksan, Muwangro 895, South Korea

Outcomes

Primary Outcomes

Change in NDI-K functional dyspepsia score

Time frame: Change from baseline at 4 weeks

Secondary Outcomes

Change in overall treatment score of patients

Time frame: Change from baseline at 4 weeks

Data from ClinicalTrials.gov

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