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Trial record 3 of 220 for:    1401

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

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ClinicalTrials.gov Identifier: NCT03443804
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

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
Gastritis Acute Gastritis Chronic Drug: Test(DW1401) Drug: Reference(Stillen tab.) Phase 3

Study Type : Interventional  (Clinical Trial)
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 : July 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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



Primary Outcome Measures :
  1. The efficacy rate on gastroscopy [ Time Frame: 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 [ Time Frame: 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




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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03443804     History of Changes
Other Study ID Numbers: DW1401-302
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan for IPD.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases