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

Chronic Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01813812
• Other study ID #: DA6034_Gas_III (Version 4.3)
• Status: Recruiting
• Phase: Phase 3
• First received: March 13, 2013
• Last updated: March 20, 2013
• Start date: October 2010

Study information

• Verified date: March 2013
• Source: Dong-A ST Co., Ltd.
• Contact: Hyun Chae Jung, M.D., Ph.D.
• Phone: 82-2-2072-0694
• Email: snuhirb[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 492
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gastritis
• Chronic Gastritis
• Gastritis

Intervention

Drug:
• DA-6034

• Rebamipide 300mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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	2 weeks	No
Secondary	The number of erosions diagnosed by the gastroscope		2 weeks	No
Secondary	The severity of the digestive symptoms (Scale of 1 to 5)	the example of the symptoms are: epigastralgia, heartburn, acid reflux, nausea, domperidone	2 weeks	No