Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia

Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 1)

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

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Drug: DWJ1252; Drug: Gasmotin

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Hanyang University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male of 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWJ1252; DWJ1252 + Placebo of Gasmotin	Drug: DWJ1252; DWJ1252 and Placebo of Gasmotin
Active Comparator: Gasmotin; Gasmotin + Placebo of DWJ1252	Drug: Gasmotin; Gasmotin and Placebo of DWJ1252

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): April 25, 2017
• Study Completion (Actual): April 25, 2017

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: January 15, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: DW_DWJ1252002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No