Study Stopped
lack of efficacy
Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients With Gastritis
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
1 other identifier
interventional
230
1 country
1
Brief Summary
THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with Gastritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Start
First participant enrolled
July 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2018
CompletedJune 26, 2019
June 1, 2019
11 months
June 9, 2017
June 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement rates of stomach erosions by the endoscopy
At 2 weeks
Study Arms (3)
DWC20155/DWC20156 Combination Therapy
EXPERIMENTALDWC20155 Monotherapy
ACTIVE COMPARATORDWC20156 Monotherapy
ACTIVE COMPARATORInterventions
tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients with previous gastrointestinal surgery
- Patients with history of gastrointestinal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daewoong pharmatceutical
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2017
First Posted
June 12, 2017
Study Start
July 3, 2017
Primary Completion
May 17, 2018
Study Completion
May 17, 2018
Last Updated
June 26, 2019
Record last verified: 2019-06