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

D

Dong-A ST

Status and phase

Completed
Phase 4

Conditions

Chronic Gastritis
Acute Gastritis

Treatments

Drug: Stillen Tab.
Drug: Mucosta Tab.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01817556
DA9601_Gas_IV

Details and patient eligibility

About

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.

Enrollment

258 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

258 participants in 2 patient groups

Stillen Tab.
Experimental group
Description:
administered three times daily for four weeks
Treatment:
Drug: Stillen Tab.
Mucosta Tab.
Active Comparator group
Description:
administered three times daily for four weeks
Treatment:
Drug: Mucosta Tab.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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