Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia

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

Completed

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Key information

Conditions

Functional Dyspepsia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWJ1252

Drug

DWJ1252 and Placebo of Gasmotin

Gasmotin

Drug

Gasmotin and Placebo of DWJ1252

Primary outcomes

The change from baseline in GIS (Gastrointestinal Symptom Score)

Time frame: At 4 Weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 18, 2017
Registry last updated: Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed