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Completed

NCT Number: NCT03184402

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

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

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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

Smg-Snu Boramae 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 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

Treatment and study plan

DWJ1252

Drug

tablet

Gasmotin

Drug

tablet

Placebo of Gasmotin

Drug

tablet

Placebo of DWJ1252

Drug

tablet

Primary outcomes

  1. 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 2)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 12, 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.

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