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

Chronic Gastritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817556
• Other study ID #: DA9601_Gas_IV
• Status: Completed
• Phase: Phase 4
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: April 2021
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastritis
• Chronic Gastritis
• Gastritis

Intervention

Drug:
• Stillen Tab.

• Mucosta Tab.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital, IRB	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement rates of erosive gastritis	Improvement rates of erosive gastritis (%); = (improved cases)/(total cases administered) * 100	4 weeks
Secondary	Healing rates of erosive gastritis	Healing rates of erosive gastritis (%); = (healed cases)/(total cases administered)*100	4 weeks
Secondary	Symptoms improved level		4 weeks