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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03443804
Other study ID # DW1401-302
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT06151210 - Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis Phase 3
Completed NCT06269380 - Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy N/A