A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT01817556

Collaborator

(none)

258

Enrollment

Location

Arms

Duration (Months)

21.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Gastritis Chronic Gastritis	Drug: Stillen Tab. Drug: Mucosta Tab.	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stillen Tab. administered three times daily for four weeks	Drug: Stillen Tab.
Active Comparator: Mucosta Tab. administered three times daily for four weeks	Drug: Mucosta Tab.

Arm

Intervention/Treatment

Experimental: Stillen Tab.

administered three times daily for four weeks

Drug: Stillen Tab.

Active Comparator: Mucosta Tab.

administered three times daily for four weeks

Drug: Mucosta Tab.

Outcome Measures

Primary Outcome Measures

Improvement rates of erosive gastritis [4 weeks]
Improvement rates of erosive gastritis (%) = (improved cases)/(total cases administered) * 100

Secondary Outcome Measures

Healing rates of erosive gastritis [4 weeks]
Healing rates of erosive gastritis (%) = (healed cases)/(total cases administered)*100
Symptoms improved level [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital, IRB	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Dong-A ST Co., Ltd.

Investigators

Principal Investigator: Yong Chan Lee, M.D., Ph.D., Yonsei University, Severance Hospital of Korea
Principal Investigator: Jin Il Kim, M.D., Ph.D., The Catholic University, Yeouido St. Mary's Hospital of Korea
Principal Investigator: Kwang Ro Joo, M.D., Ph.D., Kyung Hee University Gangdong Hospital of Korea
Principal Investigator: Dong Il Park, M.D., Ph.D., Kangbuk Samsung Hospital of Korea
Principal Investigator: In Kyung Sung, M.D.,Ph.D., Konkuk University Hospital of Korea
Principal Investigator: Kyu Chan Huh, M.D., Ph.D., Konyang University Hospital of Korea
Principal Investigator: Jung Il Suh, M.D., Ph.D., Dongguk University Gyeongju Hospital of Korea
Principal Investigator: Su Jin Hong, M.D., Ph.D., Soon Chun Hyang University Bucheon Hospital of Korea
Principal Investigator: Jin Heung Kim, M.D., Ph.D., Ajou University Hospital of Korea
Principal Investigator: Dae Hwan Kang, M.D., Ph.D., Pusan National University Yangsan Hospital of Korea
Principal Investigator: Tae Joo Jeon, M.D., Ph.D., Inje University Sanggye Paik Hospital of Korea
Principal Investigator: Tea Oh Kim, M.D., Ph.D., Inje University Haeundae Paik Hospital of Korea
Principal Investigator: Hyun Yong Jeong, M.D., Ph.D., Chungnam National Unviersity Hospital of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong-A ST Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01817556

Other Study ID Numbers:

DA9601_Gas_IV

First Posted:

Mar 25, 2013

Last Update Posted:

Apr 15, 2021

Last Verified:

Apr 1, 2021

Additional relevant MeSH terms:

Gastritis

Study Results

No Results Posted as of Apr 15, 2021