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

NCT03443804 | Completed Phase 3

• 1 other identifier: DW1401-302
• Study Type: interventional
• Target: 462
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastritis Acute; Gastritis Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cure rate on gastroscopy

  0, week 2

Study Arms (2)

Test(DW1401)

EXPERIMENTAL

tid PO, DW1401+Placebo of Stillen tab.

Drug: Test(DW1401)

Reference(Stillen tab.)

ACTIVE COMPARATOR

tid PO, Stillen tab.+Placebo of DW1401

Drug: Reference(Stillen tab.)

Interventions

Test(DW1401) DRUG

DW1401+Placebo of Stillen tab.

Test(DW1401)

Reference(Stillen tab.) DRUG

Stillen tab.+Placebo of DW1401

Reference(Stillen tab.)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: February 23, 2018
• Study Start: July 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share