search
Back to results

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

Primary Purpose

Gastritis

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWC20155
DWC20156
placebo of DWC20155
placebo of DWC20156
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daewoong pharmatceutical

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

DWC20155/DWC20156 Combination Therapy

DWC20155 Monotherapy

DWC20156 Monotherapy

Arm Description

Outcomes

Primary Outcome Measures

Improvement rates of stomach erosions by the endoscopy

Secondary Outcome Measures

Full Information

First Posted
June 9, 2017
Last Updated
June 25, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
search

1. Study Identification

Unique Protocol Identification Number
NCT03184415
Brief Title
Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients With Gastritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
lack of efficacy
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
May 17, 2018 (Actual)
Study Completion Date
May 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DWC20155/DWC20156 Combination Therapy
Arm Type
Experimental
Arm Title
DWC20155 Monotherapy
Arm Type
Active Comparator
Arm Title
DWC20156 Monotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DWC20155
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
DWC20156
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
placebo of DWC20155
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
placebo of DWC20156
Intervention Description
tablet
Primary Outcome Measure Information:
Title
Improvement rates of stomach erosions by the endoscopy
Time Frame
At 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Daewoong pharmatceutical
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs