Efficacy and Safety of DWC20155/DWC20156 Combination Ther... | NCT03184415

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

NCT03184415

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Terminated

Last Update Posted

Jun 26, 2019Actual

Enrollment

230Actual

Phase

Phase 3

Conditions

Gastritis

Interventions

DWC20155
DWC20156
placebo of DWC20155
placebo of DWC20156

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of efficacy

Expanded Access Info

Start Date

Jul 3, 2017Actual

Primary Completion Date

May 17, 2018Actual

Completion Date

May 17, 2018Actual

First Submitted Date

Jun 9, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2019

Last Update Posted Date

Jun 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
DWC20155/DWC20156 Combination Therapy	Experimental	Drug: DWC20155 Drug: DWC20156 Drug: placebo of DWC20155
DWC20155 Monotherapy	Active Comparator	Drug: DWC20155 Drug: placebo of DWC20155 Drug: placebo of DWC20156
DWC20156 Monotherapy	Active Comparator	Drug: DWC20156 Drug: placebo of DWC20155

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWC20155	Drug	tablet	DWC20155 Monotherapy DWC20155/DWC20156 Combination Therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daewoong pharmatceutical		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D005756	Gastritis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D013272	Stomach Diseases

Browse Leaves

Not provided

Browse Branches

Not provided