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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01817556

Enrollment

258

Registered

2013-03-25

Start date

2012-10-31

Completion date

2013-10-31

Last updated

2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastritis, Chronic Gastritis

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.

Interventions

DRUGStillen Tab.

DRUGMucosta Tab.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement rates of erosive gastritis	4 weeks	Improvement rates of erosive gastritis (%) = (improved cases)/(total cases administered) \* 100

Secondary

Measure	Time frame	Description
Healing rates of erosive gastritis	4 weeks	Healing rates of erosive gastritis (%) = (healed cases)/(total cases administered)\*100
Symptoms improved level	4 weeks	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026