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

Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 2)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03184402
Enrollment
124
Registered
2017-06-12
Start date
2017-04-24
Completion date
2017-07-31
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Brief summary

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

Interventions

DRUGDWJ1252

tablet

DRUGGasmotin

tablet

DRUGPlacebo of Gasmotin

tablet

DRUGPlacebo of DWJ1252

tablet

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The change from baseline in GIS (Gastrointestinal Symptom Score)At 4 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026