Skip to main content
OpenTrials
Completed

NCT Number: NCT01817556

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Gastritis Chronic Gastritis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yonsei University Health System, Severance Hospital, IRB

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stillen Tab.

Drug

Mucosta Tab.

Drug

Primary outcomes

  1. Improvement rates of erosive gastritis

    Time frame: 4 weeks

    Improvement rates of erosive gastritis (%)

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

Secondary outcomes

  1. Healing rates of erosive gastritis

    Time frame: 4 weeks

    Healing rates of erosive gastritis (%)

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

  2. Symptoms improved level

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2013
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.