Efficacy and Safety of DWJ1252 in the Treatment of Functi... | NCT03184402

Studies
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)

NCT03184402

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Jun 26, 2019Actual

Enrollment

124Actual

Phase

Phase 3

Conditions

Functional Dyspepsia

Interventions

DWJ1252
Gasmotin
Placebo of Gasmotin
Placebo of DWJ1252

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2017Actual

Primary Completion Date

Jul 31, 2017Actual

Completion Date

Jul 31, 2017Actual

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

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

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DWJ1252	Experimental		Drug: DWJ1252 Drug: Placebo of Gasmotin
Gasmotin	Active Comparator		Drug: Gasmotin Drug: Placebo of DWJ1252

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWJ1252	Drug	tablet	DWJ1252
Gasmotin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change from baseline in GIS (Gastrointestinal Symptom Score)		At 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female of at least 19 years old
Patient with functional dyspepsia met the ROME III criteria

Exclusion Criteria:

Patients with previous gastrointestinal surgery
Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
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

Name	Affiliation	Role
SMG-SNU BORAMAE MEDICAL CENTER	SMG-SNU Boramae Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Smg-Snu Boramae Medical Center		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided