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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Functional Dyspepsia

Treatments: Drug: DWJ1252; Drug: Gasmotin; Drug: Placebo of Gasmotin; Drug: Placebo of DWJ1252

Study type: Interventional

Funder types: Industry

Identifiers

NCT03184402

DW_DWJ1252003

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

DWJ1252

Experimental group

Treatment:

Drug: Placebo of Gasmotin

Drug: DWJ1252

Gasmotin

Active Comparator group

Treatment:

Drug: Gasmotin

Drug: Placebo of DWJ1252