Clinical trial NCT01817556: A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.
Official title: A Multicenter, Active-controlled, Randomized, Double-blind Paralleled-group Clinical Trial to Evaluate the Efficacy of 4-week Treatment With Stillen Tab. in Patients With Acute or Chronic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gastritis
Chronic Gastritis
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-25
Enrollment: 258
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 of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks.


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 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
* Women either pregnant or breast feeding

Primary outcomes:
measure: Improvement rates of erosive gastritis
timeFrame: 4 weeks
Secondary outcomes:
measure: Healing rates of erosive gastritis
timeFrame: 4 weeks
measure: Symptoms improved level
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital, IRB
Study officials:
affiliation: Yonsei University, Severance Hospital of Korea
name: Yong Chan Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University, Yeouido St. Mary's Hospital of Korea
name: Jin Il Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University Gangdong Hospital of Korea
name: Kwang Ro Joo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangbuk Samsung Hospital of Korea
name: Dong Il Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkuk University Hospital of Korea
name: In Kyung Sung, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konyang University Hospital of Korea
name: Kyu Chan Huh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongguk University Gyeongju Hospital of Korea
name: Jung Il Suh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soon Chun Hyang University Bucheon Hospital of Korea
name: Su Jin Hong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University Hospital of Korea
name: Jin Heung Kim, 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: Inje University Sanggye Paik Hospital of Korea
name: Tae Joo Jeon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Haeundae Paik Hospital of Korea
name: Tea Oh Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National Unviersity Hospital of Korea
name: Hyun Yong Jeong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: