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

Gastritis Chronic Clinical Trial

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Official title:

A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase 3 Clinical Trial to Evaluated the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443804
• Other study ID #: DW1401-302
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2018
• Last updated: February 26, 2018
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: February 2018
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastritis
• Gastritis Acute
• Gastritis Chronic

Intervention

Drug:
• Test(DW1401)
DW1401+Placebo of Stillen tab.
• Reference(Stillen tab.)
Stillen tab.+Placebo of DW1401

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy rate on gastroscopy	The efficacy rate is obtained from the following formula using the subject whose erroneous score is improved by 50% or more as compared with before the study drug administration.; The efficacy rate(%) = (number of effective cases)/(all cases) x 100; Effective case is determined by the grade change of erosion. A case in which the grade changes from 4 to 2 or 1, from 3 to 1, or from 2 to 1 is judged as an effective case.	0, week 2
Secondary	Cure rate on gastroscopy	Judging from the gastroscopic examination as normal (no erosion), the cure rate is obtained as follows.; Cure rate(%) = (number of cures(no erosion))/(all cases) x 100	0, week 2