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

Phase 3

Completed

• Conditions: Functional Dyspepsia
• Interventions: Drug: DWJ1252; Drug: Gasmotin; Drug: Placebo of Gasmotin; Drug: Placebo of DWJ1252

• Registration Number: NCT03184402
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-24
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWJ1252	DWJ1252	-
DWJ1252	Placebo of Gasmotin	-
Gasmotin	Gasmotin	-
Gasmotin	Placebo of DWJ1252	-

Primary Outcome Measures

Name	Time	Method
The change from baseline in GIS (Gastrointestinal Symptom Score)	At 4 weeks

Trial Locations

Locations (1)

Smg-Snu Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of