Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

Phase 3

Completed

• Conditions: Functional Dyspepsia
• Interventions: Drug: DA-5212; Drug: DA-5212-R

• Registration Number: NCT05842408
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2023-06-06
• Primary Completion: 2024-09-04
• Study Completion: 2024-09-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-5212	DA-5212	administered once daily for 4weeks
DA-5212-R	DA-5212-R	administered once daily for 4weeks

Primary Outcome Measures

Name	Time	Method
Change in NDI-K functional dyspepsia score	Change from baseline at 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in overall treatment score of patients	Change from baseline at 4 weeks

Trial Locations

Locations (1)

Wonkwang University Hospital; 🇰🇷 Iksan, Muwangro 895, Korea, Republic of