Clinical trial NCT01813812: A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Gastritis
Chronic Gastritis
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 492
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 2 weeks
Secondary outcomes:
measure: The number of erosions diagnosed by the gastroscope
timeFrame: 2 weeks
measure: The severity of the digestive symptoms (Scale of 1 to 5)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyun Chae Jung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University Yeouido St. Mary's Hopspital
name: Soo Heon Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Seong Woo Jeon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Ansan Hospital
name: Sang Woo Lee, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Dong Ho Lee, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Kook Lae Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Ju Yung Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Ki Myeong Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital, Yonsei University
name: Yongchan Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Sang Yong Seol, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jeong Seop Moon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Jong Sun Rew, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Soo Taek Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chosun University Hospital
name: Chan Kook Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Jae Gyu Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: Sei Jin Youn, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Medical Center
name: Hak Yang Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Byung Chul Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Suck Chei Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Mokdong Hospital
name: Ki Nam Shim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: