Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

December 10, 2024 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Muwangro 895
      • Iksan, Muwangro 895, Korea, Republic of, 54538
        • Wonkwang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-5212
administered once daily for 4weeks
Drug: DA-5212
Test drug: DA-5212
Other: DA-5212-R
administered once daily for 4weeks
Drug: DA-5212-R
Control drug: DA-5212-R

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Actual)

September 4, 2024

Study Completion (Actual)

September 4, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA5212_FDQ_III

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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