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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03184402
Other study ID # DW_DWJ1252003
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 24, 2017
Est. completion date July 31, 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 July 31, 2017
Est. primary completion date July 31, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
DWJ1252
tablet
Gasmotin
tablet
Placebo of Gasmotin
tablet
Placebo of DWJ1252
tablet

Locations

Country Name City State
Korea, Republic of Smg-Snu Boramae 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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