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NCT03024086 Clinical Trial

Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia

Functional Dyspepsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03024086
Other study ID # DW_DWJ1252002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 12, 2016
Est. completion date April 25, 2017

Study information
Verified date June 2019
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date April 25, 2017
Est. primary completion date April 25, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWJ1252
DWJ1252 and Placebo of Gasmotin
• Gasmotin
Gasmotin and Placebo of DWJ1252

Locations
Country Name City State
Korea, Republic of Hanyang University Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change from baseline in GIS (Gastrointestinal Symptom Score) At 4 Weeks
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