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To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients

NCT ID: NCT03443804

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-11-30

Brief Summary

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Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis

Detailed Description

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Conditions

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Gastritis Acute Gastritis Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Test(DW1401)

tid PO, DW1401+Placebo of Stillen tab.

Group Type EXPERIMENTAL

Test(DW1401)

Intervention Type DRUG

DW1401+Placebo of Stillen tab.

Reference(Stillen tab.)

tid PO, Stillen tab.+Placebo of DW1401

Group Type ACTIVE_COMPARATOR

Reference(Stillen tab.)

Intervention Type DRUG

Stillen tab.+Placebo of DW1401

Interventions

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Test(DW1401)

DW1401+Placebo of Stillen tab.

Intervention Type DRUG

Reference(Stillen tab.)

Stillen tab.+Placebo of DW1401

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.
* At least one or more erosions have been identified on gastroscopy.
* Patients who decided to voluntarily participate in this trial and agreed in writing.

Exclusion Criteria

* Patients who can not undergo gastroscopy
* Peptic ulcer (except scarring) and reflux esophagitis
* Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)
* Patients with a history of gastrointestinal malignancies
* Zollinger-Ellison syndrome patients
* Patient with spontaneous coagulation disorder
* Patients with an allergic or hypersensitive response to a study drug
* Patients with a potential pregnancy.
* Patients who had clinically significant abnormalities in the screening test. (ALT, AST, BUN, Serum creatinine is more than twice the upper limit)
* Pregnant and lactating women
* Those currently taking other study drugs
* patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW1401-302

Identifier Type: -

Identifier Source: org_study_id