A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034 Compared With Rebamipide in Patients With Acute or Chronic Gastritis

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01813812

Enrollment

492

Registered

2013-03-19

Start date

2010-10-31

Completion date

Unknown

Last updated

2013-03-22

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

Conditions

Acute Gastritis, Chronic Gastritis

Brief summary

This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.

Interventions

DRUGDA-6034

DRUGRebamipide 300mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Diagnosed with acute gastritis or chronic gastritis * 1 or more erosions found in the gastroscope examination * Age should be: 20≤age≤75

Exclusion criteria

* A patient with peptic ulcer and a gastroesophageal reflux disease. * Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation * Had a surgery regarding gastroesophageal * A patient with Zollinger-Ellison syndrome * Had a medical history of a malignant tumor * A patient who is currently taking anti-thrombotic drugs

Design outcomes

Primary

Measure	Time frame	Description
The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).	2 weeks	The scale is classified into 5 steps which are based on the severity of the improvement. EX) noticable improvement: 4-\>1, 3-\>1, slight improvement: 4-\>3, 3-\>2

Secondary

Measure	Time frame	Description
The number of erosions diagnosed by the gastroscope	2 weeks	—
The severity of the digestive symptoms (Scale of 1 to 5)	2 weeks	the example of the symptoms are: epigastralgia, heartburn, acid reflux, nausea, domperidone

Countries

South Korea

Contacts

Primary ContactHyun Chae Jung, M.D., Ph.D.

snuhirb@gmail.com82-2-2072-0694

Outcome results

None listed

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