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

Sponsor

Dong-A Pharmaceutical Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01813812

Collaborator

(none)

492

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Gastritis Chronic Gastritis	Drug: DA-6034 Drug: Rebamipide 300mg	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

492 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DA-6034 45mg two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.	Drug: DA-6034
Experimental: DA-6034 90mg two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.	Drug: DA-6034
Active Comparator: Rebamipide 300mg two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.	Drug: Rebamipide 300mg

Arm

Intervention/Treatment

Experimental: DA-6034 45mg

two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.

Drug: DA-6034

Experimental: DA-6034 90mg

two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.

Drug: DA-6034

Active Comparator: Rebamipide 300mg

two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.

Drug: Rebamipide 300mg

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

Dong-A Pharmaceutical Co., Ltd.

Investigators

Principal Investigator: Hyun Chae Jung, M.D., Ph.D., Seoul National University Hospital
Principal Investigator: Soo Heon Park, M.D., Ph.D., Catholic University Yeouido St. Mary's Hopspital
Principal Investigator: Seong Woo Jeon, M.D., Ph.D., Kyungpook National University Hospital
Principal Investigator: Sang Woo Lee, M.D.,Ph.D., Korea University Ansan Hospital
Principal Investigator: Dong Ho Lee, M.D.,Ph.D., Seoul National University Bundang Hospital
Principal Investigator: Kook Lae Lee, M.D., Ph.D., SMG-SNU Boramae Medical Center
Principal Investigator: Ju Yung Cho, M.D., Ph.D., Soonchunhyang University Hospital
Principal Investigator: Ki Myeong Lee, M.D., Ph.D., Ajou University School of Medicine
Principal Investigator: Yongchan Lee, M.D., Ph.D., Severance Hospital, Yonsei University
Principal Investigator: Sang Yong Seol, M.D., Ph.D., Inje University
Principal Investigator: Jeong Seop Moon, M.D., Ph.D., Inje University
Principal Investigator: Jong Sun Rew, M.D., Ph.D., Chonnam National University Hospital
Principal Investigator: Soo Taek Lee, M.D., Ph.D., Chonbuk National University Hospital
Principal Investigator: Chan Kook Park, M.D., Ph.D., Chosun University Hospital
Principal Investigator: Jae Gyu Kim, M.D., Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Principal Investigator: Sei Jin Youn, M.D., Ph.D., Chungbuk National University Hospital
Principal Investigator: Hak Yang Kim, M.D., Ph.D., Hallym University Medical Center
Principal Investigator: Byung Chul Yoon, M.D., Ph.D., Hanyang University
Principal Investigator: Suck Chei Choi, M.D., Ph.D., Wonkwang University Hospital
Principal Investigator: Ki Nam Shim, M.D., Ph.D., Ewha Womans University Mokdong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong-A Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01813812

Other Study ID Numbers:

DA6034_Gas_III (Version 4.3)

First Posted:

Mar 19, 2013

Last Update Posted:

Mar 22, 2013

Last Verified:

Mar 1, 2013

Additional relevant MeSH terms:

Gastritis

Rebamipide

Study Results

No Results Posted as of Mar 22, 2013