NCT03024086

Brief Summary

The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 12, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2017

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

December 29, 2016

Last Update Submit

June 25, 2019

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • The change from baseline in GIS (Gastrointestinal Symptom Score)

    At 4 Weeks

Study Arms (2)

DWJ1252

EXPERIMENTAL

DWJ1252 + Placebo of Gasmotin

Drug: DWJ1252

Gasmotin

ACTIVE COMPARATOR

Gasmotin + Placebo of DWJ1252

Drug: Gasmotin

Interventions

DWJ1252DRUG

DWJ1252 and Placebo of Gasmotin

DWJ1252
GasmotinDRUG

Gasmotin and Placebo of DWJ1252

Gasmotin

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Medical Center

Seoul, South Korea

Location

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

December 29, 2016

First Posted

January 18, 2017

Study Start

December 12, 2016

Primary Completion

April 25, 2017

Study Completion

April 25, 2017

Last Updated

June 26, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)