Clinical trial NCT02282670: A Study to Evaluate the Efficacy and Safety of DA-5204
Official title: A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5204 and to Demonstrate the Non-inferiority of DA-5204 Compared With Stillen Tab. 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: 2014-11-04
Enrollment: 434
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, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.


Eligibility criteria: Inclusion Criteria:

* Age is over 20 years old, under 75 years old, men or women
* Patients diagnosed with acute or chronic gastritis by gastroscopy
* Patients with one or more erosions found by gastroscopy
* Signed the informed consent forms

Exclusion Criteria:

* Patients who is impossible to receive gastroscopy
* Patients with peptic ulcer and gastroesophageal reflux disease
* Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
* Patients with surgery related to gastroesophageal
* Patients with Zollinger-Ellison syndrome
* Patients with any kind of malignant tumor
* Patients administered with anti-thrombotic drugs
* Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
* Patients with neuropsychiatric disorder, alcoholism, or drug abuse
* Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
* Women either pregnant or breast feeding

Primary outcomes:
measure: A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
timeFrame: 2 weeks
Secondary outcomes:
measure: A percentage of completely cured subject after a treatment
timeFrame: 2 weeks
measure: A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Universtiy, Bundang Hospital, IRB
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital of Korea
name: Dong Ho Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University, Seoul St. Mary's Hospital of Korea
name: Myung Gyu Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangwon National University Hospital of Korea
name: Sung Joon Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungbuk National University Hospital of Korea
name: Sung Kuk Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National Universtiy Hospital of Korea
name: Geun Am Song, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center of Korea
name: Poong Lyeol Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center of Korea
name: Hwoon Yong Jung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Yangsan Hospital of Korea
name: Dae Hwan Kang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yonsei University, Severance Hospital of Korea
name: Yong Chan Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Hospital of Korea
name: Si Hyung Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital of Korea
name: Suck Chei Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Medical Center of Korea
name: Gi Nam Sim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Busan Paik Hospital of Korea
name: Sang Young Seoul, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Seoul Paik Hospital of Korea
name: Jeong Seop Moon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital of Korea
name: Yong Woon Shin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National Universtiy Hospital of Korea
name: Hyen Soo Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National Universtiy Hospital of Korea
name: Soo Teik Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Presbyterian medical center in Jeonju of Korea
name: Jin Woong Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jeju National Universtiy Hospital of Korea
name: Eun Kwang Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital of Korea
name: Soon Man Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang Universtiy Hospital of Korea
name: Oh Young Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University Hospital of Korea
name: Jin Seok Jang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi YJ, Lee DH, Choi MG, Lee SJ, Kim SK, Song GA, Rhee PL, Jung HY, Kang DH, Lee YC, Lee SH, Choi SC, Shim KN, Seol SY, Moon JS, Shin YW, Kim HS, Lee ST, Cho JW, Choi EK, Lee OY, Jang JS. Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study. J Korean Med Sci. 2017 Nov;32(11):1807-1813. doi: 10.3346/jkms.2017.32.11.1807.