Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients With Gastritis

June 25, 2019 updated by: Daewoong Pharmaceutical Co. LTD.

A Multi-Center, Randomized, Parallel, Double-Blind, Phase III Clinical Trial to Compare the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy With DWC20155 or DWC20156 Monotherapy in Patients With Gastritis

THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with Gastritis

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male of female of at least 19 years old
  • Patients diagnosed with acute or chronic gastritis by gastroscopy
  • Patients with one or more erosions found by gastroscopy

Exclusion Criteria:

  • Patients with peptic ulcer and gastroesophageal reflux disease
  • Patients with previous gastrointestinal surgery
  • Patients with history of gastrointestinal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DWC20155/DWC20156 Combination Therapy
Drug: DWC20155
tablet
Drug: DWC20156
tablet
Drug: placebo of DWC20155
tablet
ACTIVE_COMPARATOR: DWC20155 Monotherapy
Drug: DWC20155
tablet
Drug: placebo of DWC20155
tablet
Drug: placebo of DWC20156
tablet
ACTIVE_COMPARATOR: DWC20156 Monotherapy
Drug: DWC20156
tablet
Drug: placebo of DWC20155
tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement rates of stomach erosions by the endoscopy
Time Frame: At 2 weeks
At 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 3, 2017

Primary Completion (ACTUAL)

May 17, 2018

Study Completion (ACTUAL)

May 17, 2018

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (ACTUAL)

June 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWJ1366006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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