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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01817556
First received: March 21, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Acute Gastritis
Chronic Gastritis
Drug: Stillen Tab.
Drug: Mucosta Tab.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Improvement rates of erosive gastritis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Improvement rates of erosive gastritis (%)

    = (improved cases)/(total cases administered) * 100



Secondary Outcome Measures:
  • Healing rates of erosive gastritis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Healing rates of erosive gastritis (%)

    = (healed cases)/(total cases administered)*100


  • Symptoms improved level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817556

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01817556     History of Changes
Other Study ID Numbers: DA9601_Gas_IV
Study First Received: March 21, 2013
Last Updated: November 5, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Gastritis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014