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

Sponsor
Daewon Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03443804
Collaborator
(none)
462
Enrollment
2
Arms
4
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
462 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test(DW1401)

tid PO, DW1401+Placebo of Stillen tab.

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

tid PO, Stillen tab.+Placebo of DW1401

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

Outcome Measures

Primary Outcome Measures

  1. The efficacy rate on gastroscopy [0, week 2]

    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.

Secondary Outcome Measures

  1. Cure rate on gastroscopy [0, week 2]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Daewon Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03443804
Other Study ID Numbers:
  • DW1401-302
First Posted:
Feb 23, 2018
Last Update Posted:
Feb 28, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastritis

Study Results

No Results Posted as of Feb 28, 2018