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

Phase 4

Completed

• Conditions: Acute Gastritis; Chronic Gastritis
• Interventions: Drug: Stillen Tab.; Drug: Mucosta Tab.

• Registration Number: NCT01817556
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-25
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stillen Tab.	Stillen Tab.	administered three times daily for four weeks
Mucosta Tab.	Mucosta Tab.	administered three times daily for four weeks

Primary Outcome Measures

Name	Time	Method
Improvement rates of erosive gastritis	4 weeks	Improvement rates of erosive gastritis (%); = (improved cases)/(total cases administered) \* 100

Secondary Outcome Measures

Name	Time	Method
Healing rates of erosive gastritis	4 weeks	Healing rates of erosive gastritis (%); = (healed cases)/(total cases administered)\*100
Symptoms improved level	4 weeks

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital, IRB; 🇰🇷 Seoul, Korea, Republic of